MEDTRONIC(R) TRANSVENE LEAD SYSTEM
FDA premarket approval P920015 · decided 1993-12-09
Approval details
- PMA number
- P920015
- Trade name
- MEDTRONIC(R) TRANSVENE LEAD SYSTEM
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 1992-04-01
- Decision date
- 1993-12-09
- Days to decision
- 617 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Mounds View, MN
- Statement
- Approval for the Medtronic Transvene® Lead System. This device is intended for single long-term use and each lead is designed to be used only with a compatible Medtronic implantable tachyarrhytmia control device along with at least one other Medtronic defibrillation lead. The lead system has application where implantable e tachyarrhythmia cardioversion or defibrillation systems are indicated. Current medical research indicates that such patients should: (1) have survived at least one episode of
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |