CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System

FDA premarket approval P130021/S033 · decided 2017-07-10

Approval details

PMA number

P130021

Supplement

S033

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Medtronic, Inc.

Date received

2017-03-06

Decision date

2017-07-10

Days to decision

126 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Miinneapolis, MN

Statement

Approval for the Medtronic CoreValve System, CoreValve Evolut R System, and CoreValve Evolut PRO System. 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and

510(k) clearances by this applicant