MODELS 5342 & 5345 TEMPORARY PULSE GENERATORS
FDA premarket approval P820003/S057 · decided 1991-02-06
Approval details
- PMA number
- P820003
- Supplement
- S057
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODELS 5342 & 5345 TEMPORARY PULSE GENERATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1991-01-04
- Decision date
- 1991-02-06
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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