MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS
FDA premarket approval P890003/S043 · decided 1996-07-01
Approval details
- PMA number
- P890003
- Supplement
- S043
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1996-02-09
- Decision date
- 1996-07-01
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MARKETING OF A SUBSET OF PULSE GENERATROS FROM THE APPROVED THERA-I/PRODIGY HARDWARE AND SOFTWARE PLATFORMS. THE DEVICES AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:MEDTRONIC:THERA MODEL 7968I PULSE GENERATOR; PRODIGY MODEL 8158 PULSE GENERATOR; PREVA MODELS 7088, 7089, 8088, AND 8089 PULSE GENERATORS; MODELS 9898E AND 9899E SOFTWARE - VITATRON:LEGACY II MODELS 126/128/526/528/726/728/826/828 PULSE GENERATORS; VISA MODELS 115/116/415/416/425/426/435/436 PULSE GENER
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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 |