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 | MECHANICAL HEART VALVE SJM(R) MASTER SERIES |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S038 |
Date Received | 08/15/1995 |
Decision Date | 03/13/1996 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE (ALL CURRENTLY APPROVED MODELS) AND THE COATED AORTIC VALVED GRAFT (CAVG), MODEL CAVG-404 |
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