SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE
FDA premarket approval P890003/S042 · decided 1995-10-31
Approval details
- PMA number
- P890003
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1995-08-16
- Decision date
- 1995-10-31
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO MARKET SOFTWARE (MODEL 9889E) WHICH IS DESIGNED TO PROVIDE PROGRAMMING CAPABILITIES, USING THE ALREADY APPROVED 9790 AND 9790A PROGRAMMERS FOR THREE MODELS OF PULSE GENERATORS AS RELABELED FOR DISTRIBUTION BY ANOTHER COMPANY, CPI UNDER THEIR TRADE NAMES. THE PACEMAKERS ARE: THE LEGEND TO BE RELABELED AS TRIUMPH VR, ELITE TO BE RELABELED AS PRELUDE DR AND SYNERGYST II TO BE RELABELED AS TRIUMPH DR.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |