M/s St. Jude Medical India Pvt. Ltd
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 8 |
| Class B | Low–moderate risk | 35 |
| Class C | Moderate–high risk | 78 |
| Class D (high risk) | Highest-risk devices | 500 |
CDSCO device licences
The TactiSys? Quartz Equipment and accessories are intended to be used in conjunction with compatible contact force ablation catheters to assist in the treatment of arrhythmias through the visualization of the force information coming from …
IMP/MD/2023/001406 · from United StatesThe Durata? defibrillation leads are indicated for use in combination with implantable cardioverter defibrillator (ICDs) or cardiac resynchronization therapy?defibrillators (CRT?D) to provide sensing, pacing and cardioversion/defibrillation…
IMP/MD/2021/000767 · from United StatesIntended Purpose: The AVEIR? Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built?in battery and electrodes for implantation in the right ventricle and the right atrium. The LP is intended to pro…
IMP/MD/2023/000825 · from United StatesThe Agilis NxT Steerable Introducer Dual-Reach is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
IMP/MD/2026/000288 · from United StatesThe Durata? defibrillation leads are indicated for use in combination with implantable cardioverter defibrillator (ICDs) or cardiac resynchronization therapy?defibrillators (CRT?D) to provide sensing, pacing and cardioversion/defibrillation…
IMP/MD/2021/000767 · from United StatesThe Cool Point? Irrigation Pump is a peristaltic pump that is intended for use in administration of irrigation solution into the patient through an open irrigated ablation catheter. The Cool Point Pump is intended for use only with the Cool…
IMP/MD/2020/000058 · from United StatesThe Dragonfly OpStar? imaging catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar imaging cat…
IMP/MD/2019/000054 · from United StatesThe Cool Point Tubing Set is a sterile and single use device which provides access for the administration of fluids from a container. This tubing set is intended for use with the Cool Point Irrigation Pump only.
IMP/MD/2020/000058 · from United StatesThe Current PFA Generator is intended for use with compatible ablation catheters for treatment of cardiac arrhythmias during cardiac ablation procedures.
IMP/MD/2023/001406 · from United StatesThe Advisor HD Grid X Mapping Catheter, Sensor Enabled, is intended for cardiac electrophysiological mapping. The Advisor HD Grid X Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardia…
IMP/MD/2022/000217 · from United StatesIntended Purpose : The intended purpose of the CentriMag? Adult Extracorporeal Membrane Oxygenation (ECMO) Kit is to provide a preconnected circuit that is capable of providing temporary (up to 14 days) extracorporeal respiratory and hemod…
IMP/MD/2026/000126 · from United StatesThe ViewFlex? Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
IMP/MD/2020/000058 · from United StatesSteerable ablation electrophysiology catheters have been designed for intracardiac recording of complex conduction disturbances as well as for the delivery of radio frequency energy for therapeutic purposes. The catheters are indicated for…
IMP/MD/2020/000058 · from United StatesSteerable ablation electrophysiology catheters have been designed for intracardiac recording of complex conduction disturbances as well as for the delivery of radio frequency energy for therapeutic purposes. The catheters are indicated for…
IMP/MD/2020/000058 · from United StatesIt is indicated for use when ventricular epicardial attachment is required, or when a transvenous lead cannot provide effective pacing. This type of lead is useful in situations where it is required that the potential for lead dislodgement …
IMP/MD/2021/000172 · from United StatesThe HeartMate 3 Left Ventricular Assist System is intended to provide long term hemodynamic support in patients with advanced, refractory left ventricular or systemic heart failure. It is intended either for short-term support, such as a br…
IMP/MD/2026/000126 · from United StatesThe HeartMate 3 Tunneling Adapter is intended for use with the HeartMate 3 LVAS. The Tunneling Adapter is used to protect the pump cable connector from fluid and debris while being passed through the abdominal tissue.
IMP/MD/2026/000126 · from United StatesThe HeartMate 3 Modular Cable is intended for use with the HeartMate 3 LVAS. The Modular Cable connects the pump driveline to the System Controller.
IMP/MD/2026/000126 · from United StatesThe Modular Cable Cap is intended for use with the HeartMate 3 LVAS. The Modular Cable Cap protects the modular connector on the Modular Cable from fluid ingress and debris during implantation.
IMP/MD/2026/000126 · from United StatesThe Skin Coring Punch is intended for use with the HeartMate 3 LVAS. The Skin Coring Punch is a single-use device used to create a circular incision in the subdermal abdominal tissue to exteriorize the Pump Cable.
IMP/MD/2026/000126 · from United StatesThe HeartMate 3 Coring Tool is intended for use with the HeartMate 3 LVAS. The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
IMP/MD/2026/000126 · from United StatesThe System Controller is intended for use with the HeartMate 3 LVAS. The System Controller is a small computer that controls and monitors the HeartMate 3 LVAS operation
IMP/MD/2026/000126 · from United StatesThe Advisor? VL, Sensor Enabled? Circular Mapping Catheter is intended for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The Advisor VL Circular Mapping Catheter Sensor Enabled is a steerable ele…
IMP/MD/2022/000217 · from Costa RicaThe Wi?Box? AO Transmitter is indicated to condition a physiological signal from the cardiovascular system and transmit it via radiofrequency. The physiological signal can also be distributed via cable.
IMP/MD/2023/001406 · from United StatesThe Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing and ventric…
IMP/MD/2023/000825 · from United StatesThe Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing and ventric…
IMP/MD/2023/000825 · from United StatesThe FlexAbility? Ablation Catheter, Sensor Enabled? is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating focal lesions during cardiac ablation procedur…
IMP/MD/2022/000217 · from United StatesThe Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing and ventric…
IMP/MD/2023/000825 · from United StatesThe Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing and ventric…
IMP/MD/2023/000825 · from United StatesThe FlexAbility? Ablation Catheter, Sensor Enabled? is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating focal lesions during cardiac ablation procedur…
IMP/MD/2022/000217 · from Costa RicaThe Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing and ventric…
IMP/MD/2023/000825 · from United StatesThe Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing and ventric…
IMP/MD/2023/000825 · from United StatesThe PressureWire X Guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, …
IMP/MD/2020/000214 · from Costa RicaThe MitraClip? G4 System is intended for reconstruction of the insufficient mitral valve through tissue approximation.
IMP/MD/2020/000185 · from United StatesThe MitraClip? G4 System is intended for reconstruction of the insufficient mitral valve through tissue approximation.
IMP/MD/2020/000185 · from United StatesIntended Purpose: The TriClip G4 System is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. Indication: The TriClip G4 system is indicated for patients with severe, symptomatic tricuspid regurgit…
IMP/MD/2025/000725 · from United StatesIntended Purpose: The TriClip G4 System is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. Indication: The TriClip G4 system is indicated for patients with severe, symptomatic tricuspid regurgit…
IMP/MD/2025/000725 · from United StatesIntended Purpose: The Cardiac Resynchronization Therapy Defibrillator (CRT?D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia…
IMP/MD/2023/000505 · from United StatesIntended Purpose: The Cardiac Resynchronization Therapy Defibrillator (CRT?D) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia…
IMP/MD/2023/000505 · from United StatesThe FlexAbility? Ablation Catheter is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating focal lesions during cardiac ablation procedures (mapping, stim…
IMP/MD/2022/000217 · from Costa RicaThe AVEIR? Patient Transmitter (model LSRM01 and software model LSRM1000) is intended to retrieve device data from implanted Aveir? Leadless Pacemakers (LP)(s) and wirelessly transmit the retrieved data to Merlin.net? Patient Care Network (…
IMP/MD/2025/000607 · from United StatesThe AVEIR? Patient Transmitter (model LSRM01 and software model LSRM1000) is intended to retrieve device data from implanted Aveir? Leadless Pacemakers (LP)(s) and wirelessly transmit the retrieved data to Merlin.net? Patient Care Network (…
IMP/MD/2025/000607 · from SpainIntended Purpose: The Implantable Cardioverter Defibrillator (ICDs) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing an…
IMP/MD/2023/000505 · from United StatesIntended Purpose: The Implantable Cardioverter Defibrillator (ICDs) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing an…
IMP/MD/2023/000505 · from United StatesIntended Purpose: The Implantable Cardioverter Defibrillator (ICDs) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing an…
IMP/MD/2023/000505 · from United StatesThe CPS Aim? Universal slittable inner catheter (subselector/cannulator) is a delivery tool used during cardiac surgery procedures in patients indicated for cardiac resynchronization therapy (CRT) for treatment of heart failure.
IMP/MD/2024/000361 · from United StatesThe CPS Direct? SL slittable outer guide catheter is a delivery tool used during cardiac surgery procedures in patients indicated for cardiac resynchronization therapy (CRT) for treatment of heart failure.
IMP/MD/2024/000361 · from United StatesThe CPS Direct? PL peelable outer guide catheter is a delivery tool used during cardiac surgery procedures in patients indicated for cardiac resynchronization therapy (CRT) for treatment of heart failure.
IMP/MD/2024/000361 · from United StatesThe CPS Direct? Universal slittable outer guide catheter is a delivery tool used during cardiac implant procedures in patients indicated for cardiac resynchronization therapy (CRT) for treatment of heart failure.
IMP/MD/2024/000361 · from United StatesIntended Purpose: The Implantable Cardioverter Defibrillator (ICDs) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing an…
IMP/MD/2023/000505 · from MalaysiaGlobal 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.