CAPSURE(R) MODEL 5023M,5024M PACING LEADS
FDA premarket approval P850089/S017 · decided 1991-12-20
Approval details
- PMA number
- P850089
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSURE(R) MODEL 5023M,5024M PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1991-07-29
- Decision date
- 1991-12-20
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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