VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR
FDA premarket approval P820003/S002 · decided 1983-03-01
Approval details
- PMA number
- P820003
- Supplement
- S002
- Trade name
- VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1982-11-17
- Decision date
- 1983-03-01
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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