MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System
FDA premarket approval P100009/S064 · decided 2024-04-09
Approval details
- PMA number
- P100009
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-03-15
- Decision date
- 2024-04-09
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- use of an additional sterilization line, aeration room, and pre-existing preconditioning room to increase sterilization capacity at the currently approved contract sterilization facility
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