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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 MODEL T505 (AORTIC)
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC VASCULAR
PMA NumberP980043
Supplement NumberS002
Date Received05/01/2002
Decision Date10/28/2002
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the valve holders for the hancock ii bioprosthesis. The holders are to be used with the following approved valve models and sizes: hancock ii porcine bioprosthesis, model t505 (aortic, sizes 21, 23, 25, 27, and 29 mm. These aortic valves are indicated for the replacement of malfunctioning native or prosthetic aortic valves.
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