EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)

FDA premarket approval P150048 · decided 2017-06-29

Approval details

PMA number

P150048

Trade name

EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)

Generic name

heart-valve, non-allograft tissue

Applicant

Edwards Lifesciences, LLC

Date received

2015-12-28

Decision date

2017-06-29

Days to decision

549 days

Decision code

APPR

Product code

LWR

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

Approval of the Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for the replacement of native or prosthetic aortic heart valves. The Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, is indicated for the replacement of native or prosthetic aortic heart valves.

510(k) clearances by this applicant