Sapien 3 Transcatheter Heart Valve and Accessories

FDA premarket approval P140031 · Aortic valve, prosthesis, percutaneously delivered

PMA numberP140031

Approval

Applicant
Edwards Lifesciences, LLC
Received
December 22, 2014
Decision date
June 17, 2015 (APPR)
Supplements
200, latest July 29, 2026
Product code
NPT – Aortic Valve, Prosthesis, Percutaneously Delivered

Official FDA PMA record

Approval order statement

APPROVAL FOR THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE 8% OR AT A 15% RISK OF MORTALITY AT 30 DAYS).