MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
FDA premarket approval P970012 · decided 1998-01-30
Approval details
- PMA number
- P970012
- Trade name
- MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 1997-02-07
- Decision date
- 1998-01-30
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Medtronic.Kappa 400 Series Pacemakers, which includes; Medtronic.Kappa KDR 401/403 & KSR 401/403 Implantable Pulse Generators w/Medtronic.Vision (Model 9952E) Software, & Medtronic Model 9462 Remote Assistant. These devices are indicated for the following: 1)Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent w/increases in activity and/or minute ventilation; 2)Accepted patient conditions warranting chronic cardiac pacing which include: a)symp
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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 |