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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/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.
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP880003
Date Received02/02/1988
Decision Date10/28/1988
Reclassified Date 10/08/2010
Product Code LOX 
Docket Number 88M-0383
Notice Date 02/07/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S001 S003 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S051 S052 S053 S054 S055 S056 
S057 S059 S060 S061  S034 S036 S037 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S047 S048 S049 S050 S062 S063 S064 
S065 S066 S067 S072 S074 S075 S082 S092 S079 S080 S081 S097 
S096 S083 S084 S091 S077 S068 S069 S071 S088 S094 S098 S095 
S089 S090 S093 S099 S100