MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE
FDA premarket approval P820003/S068 · decided 1994-08-15
Approval details
- PMA number
- P820003
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1994-02-22
- Decision date
- 1994-08-15
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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