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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.
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
1851 east deere ave.
santa ana, CA 92705
PMA NumberP990064
Date Received10/08/1999
Decision Date07/14/2000
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 00M-1416
Notice Date 08/03/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the mosaic(r) porcine bioprosthesis, models 305 and 310 in the following sizes: model 305 (aortic) 21, 23, 25, 27 and 29 mm; model 310 (mitral) 25, 27, 29 and 31 mm. This device is indicated for the replacement of malfunctioning native or prosthetic aortic and mitral heart valves.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S009 S010 S012 
S013 S014 S015 S016 S018 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S039 S040 S041 
S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S057 S058 S059 
S060 S061 S062 S063 S064