CAPSURE(R) AND CAPSURE(R) SP PACING LEADS
FDA premarket approval P830061/S019 · decided 1993-12-21
Approval details
- PMA number
- P830061
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSURE(R) AND CAPSURE(R) SP PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1992-06-15
- Decision date
- 1993-12-21
- Days to decision
- 554 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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