ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT

FDA premarket approval P990046/S005 · decided 2002-06-07

Approval details

PMA number

P990046

Supplement

S005

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT

Generic name

HEART-VALVE, MECHANICAL

Applicant

Medtronic Ats Medical, Inc.

Date received

2001-09-24

Decision date

2002-06-07

Days to decision

256 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL TO COMBINE THE ATS OPEN PIVOT BILEAFLET HEART VALVE (APPROVED ON OCTOBER 13, 2000 UNDER P990046) WITH THE MEADOX HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT (APPROVED ON MAY 11, 1993 UNDER P840029/S005). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT, MODELS 502AG21 THROUGH 502AG29, AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES, WHERE A REPLACEMENT VALVE AND R