Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC ATS MEDICAL, INC. 3800 ANNAPOLIS LANE, SUITE 175 PLYMOUTH, MN 55447 |
PMA Number | P990046 |
Supplement Number | S005 |
Date Received | 09/24/2001 |
Decision Date | 06/07/2002 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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 REPLACEMENT OR REPAIR OF THE AORTA IS REQUIRED. |
Post-Approval Study | Show Report Schedule and Study Progress |
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