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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 BIOPROTHESIS MODELS T505, T510
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC VASCULAR
PMA NumberP980043
Supplement NumberS004
Date Received12/22/2003
Decision Date01/23/2004
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 for a modification to the instructions for use.
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