MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD
FDA premarket approval P830061/S024 · decided 1994-12-12
Approval details
- PMA number
- P830061
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1994-09-08
- Decision date
- 1994-12-12
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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