MEDTRONIC SINGLE CHAMBER PACEMAKERS
FDA premarket approval P850051/S051 · decided 1995-10-31
Approval details
- PMA number
- P850051
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SINGLE CHAMBER PACEMAKERS
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 1995-07-10
- Decision date
- 1995-10-31
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF THREE MODELS OF PULSE GENERATORS TO YOUR ACTIVITRAX CARDIAC PACING SYSTEM. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAEM OF PREVAIL (MODELS 8084, 8085, AND 8086) USING MODEL 9885E SOFTWARE WITH THE ALREADY APPROVED PROGRAMMERS MODELS 9760 AND 9790, AND MOMORYMOD MODEL 9773 FOR USE WITH THE ALREADY APPROVED MODEL 9710A PROGRAMMER.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| 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 |