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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHANCOCK II PORCINE BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Namereplacement heart valve
Regulation Number870.3925
ApplicantMEDTRONIC HEART VALVES
PMA NumberP980043
Date Received10/29/1998
Decision Date09/28/1999
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 99M-4279
Notice Date 10/15/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic hancock(r) ii bioprosthetic heart valve, models t505 (odd sizes 21 through 29 mm) and t510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S007 S008 S009 S010 S012 
S013 S014 S015 S016 S017 S018 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S032 
S033 S034 S035 S036 S037 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S047 S049 S050 
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