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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 Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecv balloon dilation catheter
Regulation Number870.5100
PMA NumberP790017
Date Received06/15/1979
Decision Date03/24/1980
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 80M-0246
Notice Date 07/18/1980
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S015 S016 S017 S018 S019 S020 
S021 S022 S025 S026 S027 S028 S031 S039 S040 
S041 S043 S044 S045 S046 S047 S049 S052 S056 
S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S071 S072 S073 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 S091 S092 S093 S094 S095 
S096 S097 S098 S099 S100 S101 S102 S103 S104 
S106 S107 S108 S109 S110