MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT
FDA premarket approval P820003/S064 · decided 1992-11-16
Approval details
- PMA number
- P820003
- Supplement
- S064
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1992-07-02
- Decision date
- 1992-11-16
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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