MitraClip G5 Delivery System
FDA premarket approval P100009/S078 · decided 2025-08-20
Approval details
- PMA number
- P100009
- Supplement
- S078
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MitraClip G5 Delivery System
- Generic name
- Mitral valve repair devices
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-07-21
- Decision date
- 2025-08-20
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NKM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for updates to the Instructions for Use (IFU) to clarify information on several preparation steps for the MitraClip G5 and TriClip G5 Delivery Systems devices due to the design differences with the MitraClip G4 and TriClip G4 Delivery Systems.
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