TriClip G4 System
FDA premarket approval P230007/S003 · decided 2024-05-31
Approval details
- PMA number
- P230007
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TriClip G4 System
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-05-01
- Decision date
- 2024-05-31
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NPS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230007.
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