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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 I BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
Applicant MEDTRONIC INC.
PMA NumberP870078
Supplement NumberS001
Date Received10/13/1989
Decision Date11/09/1989
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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