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 | S054 |
Date Received | 09/27/2000 |
Decision Date | 10/23/2000 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE AORTIC POLYESTER CUFF CONFIGURATION OF THE SJM(R) MASTER SERIES HP VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM(R) MASTER SERIES HEMODYNAMIC PLUS (HP) WITH FLEX CUFF(TM), MODEL AFHPJ-505, AVAILABLE IN AORTIC SIZES 17, 19, 21, 23, 25, AND 27 MM. |
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