MEDTRONIC(R) MODEL 5346 TEMPORARY PULSE GENERATOR
FDA premarket approval P820003/S065 · decided 1993-08-04
Approval details
- PMA number
- P820003
- Supplement
- S065
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) MODEL 5346 TEMPORARY PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1993-04-06
- Decision date
- 1993-08-04
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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