EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

FDA premarket approval P130009 · decided 2014-06-16

Approval details

PMA number

P130009

Trade name

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Edwards Lifesciences, LLC

Date received

2013-05-02

Decision date

2014-06-16

Days to decision

410 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 (THV), MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >= 40 MMHG, OR A PEAK AORTIC-JET VELOCITY OF >= 4.0 M/S), AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, OR 29 MM VALVE SYSTEM, WHO ARE JUDGED BY A HEART TEA

510(k) clearances by this applicant