M/s Boston Scientific India Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 14 |
| Class B | Low–moderate risk | 152 |
| Class C | Moderate–high risk | 157 |
| Class D (high risk) | Highest-risk devices | 129 |
CDSCO device licences
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 StatesThe Lead Extensions are intended to connect the Lead to the compatible Boston Scientific Implantable Pulse Generator (IPG).
IMP/MD/2021/000648 · from United StatesThe 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 StatesThe 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 IsraelThe 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 StatesThe 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 StatesThe 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 StatesThe 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 StatesThe 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 MalaysiaThe 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 StatesThe 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 StatesWATCHMAN FLX Pro is intended for percutaneous, transcatheter closure of the left atrial appendage.
IMP/MD/2018/000129 · from United StatesThe 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 RicaThe 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 StatesThe 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 IrelandThe 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 StatesThe 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 StatesThe 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 StatesThe 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 StatesThe 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 StatesThe 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 RicaThe 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 RicoThe 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 StatesThe 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 StatesThe 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 RicaThe 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 IrelandThe 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 StatesThe 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 IrelandThe 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 StatesThe 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 StatesThe 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 IrelandThis 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 RicaThe 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 StatesThe 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 StatesThe 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 StatesThe 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 StatesThe 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 RicaThe 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 StatesThe CSK Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only
IMP/MD/2019/000362 · from Costa RicaThe 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 StatesThe Agent DCB is intended for use in patients undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures.
IMP/MD/2025/000118 · from United StatesThe 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 StatesBoston 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 StatesThe 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 StatesThe 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 RicaFor the introduction of various types of pacing leads and catheters.
IMP/MD/2024/000948 · from United StatesThe drainage needle must only be used for intra-gastric balloons draining.
IMP/MD/2024/000925 · from FranceThe 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 FranceThis 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 RicaThe 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 IsraelGlobal footprint
Cross-railThe 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.