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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMASTERS SERIES VALVE: PTFE SEWING CUFF
Generic NameHEART-VALVE, MECHANICAL
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS052
Date Received05/22/2000
Decision Date06/30/2000
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO REMOVE THE CONDITION OF APPROVAL IN THE JULY 23,1998 APPROVAL ORDER THAT THE FIRM PROVIDE RESULTS FROM TESTS WHICH DEMONSTRATE THE LONG-TERM INTEGRITY OF THE SEWING CUFF ATTACHMENT MECHANISM OF THE ST. JUDE MEDICAL(R) MASTER SERIES VALVE MODELS.
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