Tendyne Transcatheter Mitral Valve System
FDA premarket approval P240042/S002 · decided 2025-10-04
Approval details
- PMA number
- P240042
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Tendyne Transcatheter Mitral Valve System
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-09-04
- Decision date
- 2025-10-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NPU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval of the protocol for the post-approval study, "Registry-Based Real-World Use Surveillance," submitted to comply with the conditions of approval outlined in the approval order for P240042.
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