Importer / authorised agent · Haryana · India

M/s Boston Scientific India Private Limited

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
452
Manufacturing
0
Import
452
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices14
Class BLow–moderate risk152
Class CModerate–high risk157
Class D (high risk)Highest-risk devices129

CDSCO device licences

Pulsed Field Ablation Generator · Class CIMPORT · 2026-05-04

The FARAPULSE Pulsed Field Ablation (PFA) System is intended for the isolation of the pulmonary veins in the treatment of paroxysmal atrial fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arr…

IMP/MD/2022/000231 · from United States
Lead Extension kit · Class DIMPORT · 2026-04-30

The Lead Extensions are intended to connect the Lead to the compatible Boston Scientific Implantable Pulse Generator (IPG).

IMP/MD/2021/000648 · from United States
Cryoablation Needle · Class CIMPORT · 2026-04-24

The Boston Scientific disposable IceRod Cryoablation Needle are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of …

IMP/MD/2024/000178 · from United States
Cryoablation Needle · Class CIMPORT · 2026-04-24

The Boston Scientific disposable IceSphere Cryoablation Needle are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application …

IMP/MD/2024/000178 · from Israel
Delivery Device · Class CIMPORT · 2026-03-17

The Rezum System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men more than equal to 50 years of age with a prostate volume between 30 cm3 …

IMP/MD/2022/000231 · from United States
Software · Class DIMPORT · 2026-03-17

The StimSearch Programming Assistant software is intended to be used as supporting software to optimize the process of selecting stimulation settings to try when program-ming compatible Boston Scientific Stimulators with the Vercise Neural …

IMP/MD/2025/000748 · from United States
Endoscopic Suturing System · Class BIMPORT · 2026-03-17

The OverStitch Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor-sutures can be placed for defect closure (e.g. perforation, ESD/EMR and fistula/leak), stent fixation to reduce migration rates in t…

IMP/MD/2018/000059 · from United States
Endoscopic Access System · Class BIMPORT · 2026-03-10

The OverTube is intended to be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract.

IMP/MD/2026/000175 · from United States
Everolimus-Eluting Platinum Chromium Coronary Stent System · Class DIMPORT · 2026-02-25

The SYNERGY XD Stent System is intended to improve luminal diameter in native coronary arteries with discrete, de novo stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute myocar…

IMP/MD/2019/000130 · from Malaysia
Everolimus-Eluting Platinum Chromium Coronary Stent System · Class DIMPORT · 2026-02-25

The SYNERGY Shield Stent System is intended to improve luminal diameter in native coronary arteries with discrete, de novo stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute my…

IMP/MD/2019/000130 · from United States
Steerable Sheath Clear · Class DIMPORT · 2026-02-25

The FARAPULSE PFA System is intended for the isolation of the pulmonary veins in the treatment of paroxysmal atrial fibrillation by rendering targeted cardiac tissue electrically nonconductive to prevent cardiac arrhythmia initiation or mai…

IMP/MD/2026/000158 · from United States
Left Atrial Appendage Closure Device with Delivery System · Class DIMPORT · 2026-02-13

WATCHMAN FLX Pro is intended for percutaneous, transcatheter closure of the left atrial appendage.

IMP/MD/2018/000129 · from United States
Pulsed Field Ablation Catheter · Class DIMPORT · 2026-01-30

The FARAPULSE Pulsed Field Ablation (PFA) System is intended for the isolation of the pulmonary veins in the treatment of paroxysmal atrial fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arr…

IMP/MD/2021/000122 · from Costa Rica
Pulsed Field Ablation Catheter · Class DIMPORT · 2026-01-30

The FARAPULSE Pulsed Field Ablation (PFA) System is intended for the isolation of the pulmonary veins in the treatment of paroxysmal atrial fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arr…

IMP/MD/2021/000122 · from United States
Polymer tip guidewire with hydrophilic coating · Class DIMPORT · 2025-12-17

The Victory guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature of the lower limbs during Percutaneous Transluminal Angioplasty (PTA) or oth…

IMP/MD/2025/000764 · from Ireland
Cinch · Class CIMPORT · 2025-12-16

The X-Tack System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation, or leaks). The X-Tack System is not intended …

IMP/MD/2018/000059 · from United States
Directional Lead Kit · Class DIMPORT · 2025-12-16

The Leads are medical devices that are intended to deliver stimulation from the compatible Boston Scientific Stimulator to a brain target.

IMP/MD/2021/000648 · from United States
Software · Class DIMPORT · 2025-12-16

The intended use of the Neural Navigator programming software on a Clinician Programmer platform is to set and adjust stimulation parameters for the compatible Boston Scientific Stimulator.

IMP/MD/2025/000748 · from United States
Helix Locking Tool · Class AIMPORT · 2025-12-16

The Helix Locking Tool is intended to facilitate lead fixation by providing control over the extension and retraction of the lead helix of an IS-1 pacing or defibrillator lead. It is also intended to facilitate insertion of a stylet into th…

IMP/MD/2022/000182 · from United States
Artificial Urinary Sphincter (Pressure Regulating Balloon) · Class CIMPORT · 2025-12-15

The AMS 800 AUS is used to treat urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency) in males and females.

IMP/MD/2022/000231 · from United States
Cannula · Class CIMPORT · 2025-10-24

The Boston Scientific RF Cannula is intended for use in RF heat lesion procedures for the relief of pain from peripheral nerve tissue only.

IMP/MD/2019/000362 · from Costa Rica
Adapter · Class DIMPORT · 2025-10-24

The Vercise? Adapter S8 is intended to connect compatible Abbott (St. Jude Medical) Lead Extensions to the compatible Boston Scientific Implantable Pulse Generator (IPG).

IMP/MD/2021/000648 · from Puerto Rico
Suture Cinch - Long · Class CIMPORT · 2025-10-09

The X-Tack System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation, or leaks). The X-Tack System is not intended …

IMP/MD/2018/000059 · from United States
Polypropylene Suture · Class CIMPORT · 2025-10-09

The OverStitch Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor-sutures can be placed for defect closure (e.g. perforation, ESD/EMR and fistula/leak), stent fixation to reduce migration rates in t…

IMP/MD/2018/000059 · from United States
Endoscopic HeliX Tacking System · Class CIMPORT · 2025-10-09

The X-Tack System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation, or leaks). The X-Tack System is not intended …

IMP/MD/2018/000059 · from Costa Rica
Stent system · Class CIMPORT · 2025-10-03

The WallFlex Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

IMP/MD/2018/000129 · from Ireland
Cryoablation Needle · Class CIMPORT · 2025-08-22

The Boston Scientific disposable IceSeed Cryoablation Needle is meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of …

IMP/MD/2024/000178 · from United States
Single-Use Digital Flexible Ureteroscope · Class BIMPORT · 2025-08-05

The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunct…

IMP/MD/2020/000327 · from Ireland
Digital Catheter · Class BIMPORT · 2025-07-07

The SpyGlass Discover Digital Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system in…

IMP/MD/2020/000327 · from United States
Access and Delivery Catheter · Class BIMPORT · 2025-07-07

The SpyScope DS II Access and Delivery Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary …

IMP/MD/2020/000327 · from United States
Access System · Class DIMPORT · 2025-06-17

The WATCHMAN FXD Curve Access System is intended to provide vascular and transseptal access for all WATCHMAN LAAC Devices with Delivery Systems.

IMP/MD/2018/000129 · from Ireland
Coronary Imaging Catheter · Class CIMPORT · 2025-05-22

This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

IMP/MD/2018/000059 · from Costa Rica
Lead Delivery System · Class DIMPORT · 2025-05-21

The ACUITY Pro Lead Delivery System is intended to access the coronary venous system. The ACUITY Pro 9F Guide Catheter serves as a conduit for the delivery of contrast medium and devices, including implantable Boston Scientific coronary ven…

IMP/MD/2021/000458 · from United States
Guide Catheter · Class DIMPORT · 2025-05-21

The ACUITY Pro Lead Delivery System is intended to access the coronary venous system to serve as a conduit for the delivery of contrast medium and devices, including implantable Boston Scientific coronary venous leads, introduced into the c…

IMP/MD/2021/000458 · from United States
Drug Coated Balloon Catheter · Class DIMPORT · 2025-05-01

The Ranger DCB is indicated for percutaneous transluminal angioplasty (PTA) in adults with de novo or restenotic lesions located in native superficial femoral and proximal popliteal arteries (SFA / PPA), and infrapopliteal arteries.

IMP/MD/2025/000118 · from United States
Guidewire · Class BIMPORT · 2025-04-22

The Thruway Guidewire facilitates placement of a catheter during diagnostic or interventional peripheral intravascular procedures including but not limited to renal intervention. The wire can be torqued to facilitate navigation through the …

IMP/MD/2019/000170 · from United States
Electrodes · Class DIMPORT · 2025-04-16

The Boston Scientific Disposable Stereotactic TCD Electrode is indicated for use in RF heat lesioning of nervous tissue, including the Central Nervous System.

IMP/MD/2019/000362 · from Costa Rica
Radio-Frequency Ablation System · Class CIMPORT · 2025-04-09

The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning of peripheral nerve tissue only. The nerve is localized either by electrical stimulation or …

IMP/MD/2019/000362 · from United States
Radio-Frequency Ablation system · Class CIMPORT · 2025-04-09

The CSK Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only

IMP/MD/2019/000362 · from Costa Rica
Radio-Frequency Ablation System · Class CIMPORT · 2025-03-20

The Cosman CC RF Cannula and RFK RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain from peripheral nerve tissue only.

IMP/MD/2019/000362 · from United States
Drug Coated Balloon Catheter · Class DIMPORT · 2025-02-20

The Agent DCB is intended for use in patients undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures.

IMP/MD/2025/000118 · from United States
Thermal Sensor · Class BIMPORT · 2025-02-11

The Boston Scientific disposable Multi-Point 1.5 Thermal Sensor Device (MTS) is a component used in conjunction with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cyroablative destruction of…

IMP/MD/2024/000178 · from United States
Catheter · Class BIMPORT · 2025-02-11

Boston Scientific Urethral Warming Set (UWS) is intended to warm urethral tissue when performing cryoablative destruction of prostatic tissue with a Boston Scientific cryoablation system. The disposable UWS is not intended for use when perf…

IMP/MD/2024/000178 · from United States
Thrombectomy Set · Class CIMPORT · 2025-01-14

The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from: ? upper and lower extremity peripheral arteries and ? for use with the AngioJet Ultra Power Pulse? techn…

IMP/MD/2024/000407 · from United States
Cinch · Class CIMPORT · 2025-01-13

The X-Tack? System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). The X-Tack? System is not intended …

IMP/MD/2024/000667 · from Costa Rica
Introducer Set · Class CIMPORT · 2024-11-25

For the introduction of various types of pacing leads and catheters.

IMP/MD/2024/000948 · from United States
Deflation Needle for gastric balloon · Class BIMPORT · 2024-11-22

The drainage needle must only be used for intra-gastric balloons draining.

IMP/MD/2024/000925 · from France
Extraction Forcep · Class BIMPORT · 2024-11-22

The extraction forceps are used for the extraction of intragastric balloon after emptying (realized with the drainage needle AS2640718 of PRINCE MEDICAL range).

IMP/MD/2024/000925 · from France
Peripheral Imaging Catheter · Class CIMPORT · 2024-09-25

This catheter is intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

IMP/MD/2018/000059 · from Costa Rica
Accessory Kit · Class CIMPORT · 2024-09-12

The FiberLase ENDURE CO2 laser fiber is intended for use in surgical procedures that could require ablation, vaporization, excision, incision and coagulation of soft tissue. The fiber is indicated for use in open surgical procedures such as…

IMP/MD/2022/000616 · from Israel

Global footprint

Cross-rail

The same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.

No FDA clearances linked — India-domestic footprint.

Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.

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