SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)

FDA premarket approval P810002/S058 · decided 2005-02-14

Approval details

PMA number

P810002

Supplement

S058

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

2005-01-03

Decision date

2005-02-14

Days to decision

42 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR AN ADDITIONAL CONFIGURATION OF THE AORTIC VALVED GRAFT USING THE SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) AND IS INDICATED FOR THE REPLACEMENT OF A MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE AND ASCENDING AORTA.

510(k) clearances by this applicant