MEDTRONIC CARELINK MONITOR AND CARDIOSIGHT READER
FDA premarket approval P890003/S141 · decided 2008-07-08
Approval details
- PMA number
- P890003
- Supplement
- S141
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CARELINK MONITOR AND CARDIOSIGHT READER
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2008-06-13
- Decision date
- 2008-07-08
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE CHANGES MADE TO THE MODEL 2490G MEDTRONIC CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AS FOLLOWS: 1) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE REVEAL XT AND REVEAL DX TO THE MODEL 2490G CARELINK MONITOR.2) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR TO ALLOW THE MONITOR TO FACILITATE RESETTING FIVE OF THE EI
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 |