PREMIER PACING SYSTEM
FDA premarket approval P850051/S056 · decided 2001-04-18
Approval details
- PMA number
- P850051
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PREMIER PACING SYSTEM
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2000-12-15
- Decision date
- 2001-04-18
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE PREMIER PACING SYSTEM, INCLUDING THE PREMIER MODEL 8081 VVI PACEMAKER, THE CAPSURE MODEL 4003M ENDOCARDIAL LEAD AND THE MODEL 9884 SOFTWARE FOR THE MODEL 9790 AND 9790C PROGRAMMERS.
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510(k) clearances by this applicant
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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