VERSATRAX(TM) CARDIAC PACING SYSTEM
FDA premarket approval P820003/S053 · decided 1991-05-08
Approval details
- PMA number
- P820003
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- VERSATRAX(TM) CARDIAC PACING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1990-08-14
- Decision date
- 1991-05-08
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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