MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR
FDA premarket approval P930022 · decided 1997-02-07
Approval details
- PMA number
- P930022
- Trade name
- MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 1993-07-21
- Decision date
- 1997-02-07
- Days to decision
- 1297 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE LEGEND PLUS(R) PACING SYSTEM INCLUDING THE LEGEND PLUS(R) PULSE GENERATOR MODELS 8446 AND 8448; THE MODEL 9790 AND 9790C PROGRAMMERS WITH THE MODEL 9891 BASELINE SOFTWARE AND WITH THE MODE 9807 SOFTWARE. THIS SYSTEM IS INDICATED FOR PERMANENT VENTRICULAR OR ATRIAL PACING APPLICATIONS. ITS USE IS INDICATED IN THE TREATMENT OF PATIENTS WHO MAY BENEFIT FROM A PCING RATE THAT CHAGNES IN RESPONSE TO ACTIVITY. VENTRICULAR INDICATIONS INCLUDE: 1)CHRONIC ATRIAL FLUTTER OR FIBRILLATION W
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 |