Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

FDA premarket approval P140031/S028 · decided 2017-06-05

Approval details

PMA number

P140031

Supplement

S028

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Edwards Lifesciences, LLC

Date received

2016-12-09

Decision date

2017-06-05

Days to decision

178 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Irvine, CA

Statement

Approval for the SAPIEN 3 Transcatheter Heart Valve and accessories. The device is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral 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., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the STS risk score and other clinical co-morbidit

510(k) clearances by this applicant