MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING
FDA premarket approval P830061/S009 · decided 1989-04-26
Approval details
- PMA number
- P830061
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1989-03-02
- Decision date
- 1989-04-26
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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