CAPSURE(R) AND CAPSURE(R)SP LEADS
FDA premarket approval P850089/S032 · decided 1995-10-31
Approval details
- PMA number
- P850089
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE(R) AND CAPSURE(R)SP LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-01-30
- Decision date
- 1995-10-31
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM HTE USE OF 12 PERCENT ETHYLENE OXIDE (ET0), 88 PERCENT CFC, TO 100 PERCENT ET0
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