MEDTRONIC COREVALVE SYSTEM

FDA premarket approval P130021/S002 · decided 2014-06-12

Approval details

PMA number

P130021

Supplement

S002

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

2014-02-27

Decision date

2014-06-12

Days to decision

105 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Miinneapolis, MN

Statement

APPROVAL FOR THE MEDTRONIC COREVALVE SYSTEM. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >=40 MM HG, OR A PEAK AORTIC-JET VELOCITY OF >=4.0 M/S) AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, 29, OR 31 MM VALVE SYSTEM WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH

510(k) clearances by this applicant