Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
• Generic Name: replacement Heart-valve
• Regulation Number: 870.3925
• Applicant: Medtronic, Inc.; 1851 EAST DEERE AVE.; SANTA ANA, CA 92705
• PMA Number: P990064
• Date Received: 10/08/1999
• Decision Date: 07/14/2000
• Product Code: 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: S058 S039 S040 S054 S057 S037 S012 S013 S014 S025 S053 ; S048 S049 S050 S042 S061 S044 S045 S041 S027 S010 S009 S005 ; S007 S018 S019 S020 S030 S031 S026 S035 S036 S033 S016 S062 ; S063 S068 S001 S002 S004 S052 S046 S047 S055 S056 S043 S059 ; S060 S051 S015 S006 S023 S028 S034 S032 S029 S021 S022 S024 ; S064 S069 S066 S067 S065 S073 S082 S086 S070 S074 S075 S071 ; S076 S083 S078 S080 S081 S079 S077 S084 S087 S088 S085