MitraClip NT, NTR, XTR, G4 Clip Delivery System
FDA premarket approval P100009/S034 · decided 2019-08-30
Approval details
- PMA number
- P100009
- Supplement
- S034
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MitraClip NT, NTR, XTR, G4 Clip Delivery System
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-08-06
- Decision date
- 2019-08-30
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for manufacturing process changes to reduce Clip Arm spread variability and to implement an inspection for final Clip Arm spread.
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