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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 BIOPROSTHESIS, MODELS T505 AND T510
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC VASCULAR
PMA NumberP980043
Supplement NumberS009
Date Received02/06/2006
Decision Date06/05/2006
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to: 1) the jar retainer used for both the mitral aortic configurations of hancock ii bioprostheses; 2) the serial number tag for mitral and aortic configurations of the hancock ii bioprostheses; 3) the valve holder for the hanckck ii mitral bioprotheses; and 4) the "instructions for use" to accommodate the changes in the retainer, tag and mitral holder.
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