MEDTRONIC(R) 7000 VERSATRAX(R) PULSE GENERATOR
FDA premarket approval P820003/S060 · decided 1991-12-18
Approval details
- PMA number
- P820003
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC(R) 7000 VERSATRAX(R) PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1991-11-05
- Decision date
- 1991-12-18
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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