9751B SYSTEM ENHANCEMENT MODULE PRINTER
FDA premarket approval P820003/S059 · decided 1991-09-27
Approval details
- PMA number
- P820003
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 9751B SYSTEM ENHANCEMENT MODULE PRINTER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1991-07-29
- Decision date
- 1991-09-27
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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