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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC VASCULAR
PMA NumberP980043
Supplement NumberS001
Date Received04/08/2002
Decision Date04/16/2002
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise one caution statement and to include references to a new valve handle (model 7639) within the instructions for use.
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