MEDTRONIC PACEMAKER SYSTEM
FDA premarket approval P890003/S091 · decided 2005-11-15
Approval details
- PMA number
- P890003
- Supplement
- S091
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC PACEMAKER SYSTEM
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2005-10-05
- Decision date
- 2005-11-15
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK.
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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 |