LEGEND PLUS PACEMAKER FAMILY
FDA premarket approval P930022/S001 · decided 2002-03-13
Approval details
- PMA number
- P930022
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEGEND PLUS PACEMAKER FAMILY
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2002-02-27
- Decision date
- 2002-03-13
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROG
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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 |