2 devices · 2 companies · 2025
Product code LWS: Implantable Cardioverter Defibrillator (Non-Crt)
2 devices under product code LWS, 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (0 of 2 here), the regulation, and MAUDE report counts by product code.
Implantable Cardioverter Defibrillator (Non-Crt). These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary. MAUDE held 382,884 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Aurora EV ICDP220012/S059 · PMA | Medtronic, Inc. | Cardiovascular | database entry | |
| Cobalt MRI ICDP980016/S939 · PMA | Medtronic Cardiac Rhythm Disease Management | Cardiovascular | database entry |
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