EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES

FDA premarket approval P100041/S039 · decided 2013-09-23

Approval details

PMA number

P100041

Supplement

S039

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Edwards Lifesciences, LLC

Date received

2013-08-28

Decision date

2013-09-23

Days to decision

26 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR REMOVAL OF ACCESS APPROACH FROM DEVICE LABELING. THE DEVICE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION > 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CAND

510(k) clearances by this applicant