VARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER
FDA premarket approval P890003/S116 · decided 2007-05-04
Approval details
- PMA number
- P890003
- Supplement
- S116
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-02-28
- Decision date
- 2007-05-04
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE CARELINK V1.1 DEVICE DATA MANAGEMENT APPLICATION TO (1) PROVIDE SUPPORT FOR CONCERTO WITH ATRIAL THERAPIES; (2) ALLOW TRANSMISSION OF AN ?ALERT? SIGNAL FOR AT/AF BURDEN AND FAST V RESPONSE OBSERVATIONS IF THERE IS AN ASSOCIATED ALERT; (3) OUTPUT THE TYPE OF EPISODE LOG FOR INVALID EPISODES SO CARELINK CAN PROPERLY DISPLAY INVALID EPISODES AS ARRHYTHMIA EPISODES OR VENTRICULAR SENSING EPISODES; AND (4) CORRECT A PROBLEM WHERE THE CARDIAC COMPASS ?VENTRICULAR RATE DURIN
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| 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 |