PMA P240042S002

Device: Tendyne™ Transcatheter Mitral Valve System
Applicant: ABBOTT MEDICAL
PMA number: P240042
Supplement: S002
Product code: NPU
Decision date: 2025-10-04
Classification: Cardiovascular
Generic name: Prosthesis, mitral valve, percutaneously delivered
Approval order 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.

Current openFDA PMA Record#

Device: Tendyne™ Transcatheter Mitral Valve System
Applicant: ABBOTT MEDICAL
PMA number: P240042
Supplement: S002
Product code: NPU
Generic name: Prosthesis, mitral valve, percutaneously delivered
Decision date: 2025-10-04
Decision code: APPR
Date received: 2025-09-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order 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.