CAPSURE(R) SP MODEL 5024M TRANSVENOUS PACING LEAD
FDA premarket approval P850089/S018 · decided 1992-03-05
Approval details
- PMA number
- P850089
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE(R) SP MODEL 5024M TRANSVENOUS PACING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1991-10-03
- Decision date
- 1992-03-05
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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