PMA P230007S003

Device: TriClip™ G4 System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S003
Product code: NPS
Decision date: 2024-05-31
Classification: Cardiovascular
Generic name: Tricuspid valve repair device, percutaneously delivered
Approval order 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.

Current openFDA PMA Record#

Device: TriClip™ G4 System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S003
Product code: NPS
Generic name: Tricuspid valve repair device, percutaneously delivered
Decision date: 2024-05-31
Decision code: APPR
Date received: 2024-05-01
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 (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230007.