EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

FDA premarket approval P130009/S034 · decided 2015-10-09

Approval details

PMA number

P130009

Supplement

S034

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Edwards Lifesciences, LLC

Date received

2015-04-15

Decision date

2015-10-09

Days to decision

177 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE, MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC VALVE 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

510(k) clearances by this applicant