ST. JUDE MEDICAL REGENT MECHANICAL HEART VALVE (AORTIC)

FDA premarket approval P810002/S057 · decided 2002-03-04

Approval details

PMA number

P810002

Supplement

S057

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ST. JUDE MEDICAL REGENT MECHANICAL HEART VALVE (AORTIC)

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

2001-09-07

Decision date

2002-03-04

Days to decision

178 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR A MODIFIED VERSION OF THE SJM STANDARD VALVE, SIZES 19, 21, 23, 25 AND 27 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REGENT MECHANICAL HEART VALVE AND IS INDICATED AS A REPLACEMENT VALVE IN PATIENTS WITH A DISEASED, DAMAGED, OR MALFUNCTIONING AORTIC VALVE. THIS DEVICE MAY ALSO BE USED TO REPLACE A PREVIOUSLY IMPLANTED PROSTHETIC HEART VALVE.

510(k) clearances by this applicant