MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00

FDA premarket approval P810002/S056 · decided 2001-05-03

Approval details

PMA number

P810002

Supplement

S056

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

2001-03-26

Decision date

2001-05-03

Days to decision

38 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR CHANGES TO THE COUNTRY OF ORIGIN OF THE BOVINE COLLAGEN USED FOR THE HEMASHIELD(R) GRAFT, WHICH IS A COMPONENT OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE - MASTER SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-51400 IN SIZES 19, 21, 23, 25, 27, 29, 31, AND 33 MM, AND IS INDICATED FOR THE REPLACEMENT OF THE AORTIC VALVE AND THE ASCENDING AORTA.

510(k) clearances by this applicant