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 | ST. JUDE MEDICAL MECHANICAL HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S035 |
Date Received | 02/03/1995 |
Decision Date | 07/31/1995 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USE OF THE WOODRIDGE CARBON TECHNOLOGY CENTER, LITTLE CANADA, MINNESOTA, AS AN ALTERNATE SUPPLIER OF THE PYROLITIC CARBON LEAFLET & ORIFICE COMPONENTS USED IN THE ST.JUDE MEDICAL MECHANICAL HEART VALVE |
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