SAPIEN 3 Ultra transcatheter heart valve

FDA premarket approval P140031/S085 · decided 2019-08-16

Approval details

PMA number

P140031

Supplement

S085

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SAPIEN 3 Ultra transcatheter heart valve

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Edwards Lifesciences, LLC

Date received

2019-04-01

Decision date

2019-08-16

Days to decision

137 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are 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 appropriate for the transcatheter heart valve replacement the

510(k) clearances by this applicant