MitraClip G4 Clip Delivery System
FDA premarket approval P100009/S045 · decided 2022-08-08
Approval details
- PMA number
- P100009
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MitraClip G4 Clip Delivery System
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-01-31
- Decision date
- 2022-08-08
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for the addition of a manufacturing site located at 1820 Bastian Court, Westfield, Indiana, 46074.
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