SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

FDA premarket approval P140031/S010 · decided 2016-08-18

Approval details

PMA number

P140031

Supplement

S010

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Edwards Lifesciences, LLC

Date received

2016-02-29

Decision date

2016-08-18

Days to decision

171 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 for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 3% at

510(k) clearances by this applicant