MEDTRONIC COREVALVE SYSTEM

FDA premarket approval P130021/S010 · decided 2015-03-30

Approval details

PMA number

P130021

Supplement

S010

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MEDTRONIC COREVALVE SYSTEM

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Medtronic, Inc.

Date received

2014-12-09

Decision date

2015-03-30

Days to decision

111 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Miinneapolis, MN

Statement

APPROVAL FOR THE MEDTRONIC COREVALVE SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC 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., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS).

510(k) clearances by this applicant