MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525
FDA premarket approval P850089/S009 · decided 1989-12-19
Approval details
- PMA number
- P850089
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1988-01-03
- Decision date
- 1989-12-19
- Days to decision
- 716 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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