HANCOCK APICAL LEFT VENTRICLE CONNECTOR

FDA premarket approval P870078/S008 · decided 2010-09-20

Approval details

PMA number

P870078

Supplement

S008

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

HANCOCK APICAL LEFT VENTRICLE CONNECTOR

Generic name

replacement Heart-valve

Applicant

Medtronic, Inc.

Date received

2010-03-31

Decision date

2010-09-20

Days to decision

173 days

Decision code

APPR

Product code

DYE

Advisory committee

Cardiovascular

Expedited review

No

Location

Santa Ana, CA

Statement

APPROVAL FOR THE HANCOCK APICAL LEFT VENTRICLE CONNECTOR, MODEL 174A. THE DEVICE IS INDICATED FOR PROVIDING AN ALTERNATIVE METHOD FOR RELIEF OF LEFT VENTRICULARHYPERTENSION IN PATIENTS WITH SEVERE LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION DUE TO HYPOPLASIA OFTHE AORTIC ROOT, HYPOPLASIA OF THE AORTIC ANNULUS, OR ACQUIRED PROBLEMS SECONDARY TO AORTIC VALVE REPLACEMENT WHICH CANNOT BE RELIEVED THROUGH CONVENTIONAL TECHNIQUES.

510(k) clearances by this applicant