MitraClip G4 Clip Delivery System
FDA premarket approval P100009/S055 · decided 2023-11-20
Approval details
- PMA number
- P100009
- Supplement
- S055
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MitraClip G4 Clip Delivery System
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-05-24
- Decision date
- 2023-11-20
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for various updates to the Instructions for Use: (1) to add the final clinical results of Post-Approval Study #1, Continued Follow-up of the COAPT Trial Pivotal Cohort, ordered in our March 14, 2019, letter; (2) to remove the Anatomic Considerations section; and (3) to add the results of the postmarket EXPAND and EXPAND G4 studies.
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