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 | THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S036 |
Date Received | 05/05/1995 |
Decision Date | 11/28/1995 |
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 |
Approval Order Statement APPROVAL FOR A ROTATABLE VERSION OF THE ST.JUDE MEDICAL MECHANICAL HEART VALVE - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:ST. JUDE MEDICAL MASTER SERIES AND WILL BE AVAILABLE IN THE FOLLOWING MODEL NUMBERS AND SIZES:AJ-501 AND AECJ-502 (19, 21, 23, 25, 27, 29, AND 31 MM), MJ-501 AND MECJ-502 (19, 21, 23, 25, 27, 29, 31, AND 33MM) AND AHPJ-505, MHPJ-505, AEJPJ-506, AND MEHPJ-506 (17, 19, 21, 23, 25, AND 27MM). THE SUPPLEMENT ALSO INCLUDES A VALVE HOLDER/ROTATOR ACCESSORY WHICH WILL BE INCLUDED AS A COMPONENT OF THE MECHANICAL HEART VALVE SIZER SET MODEL 905 |
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