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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 NameCORDIS PTCA DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Date Received02/02/1988
Decision Date10/28/1988
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 88M-0383
Notice Date 02/07/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 S034 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S059 
S060 S061 S062 S063 S064 S065 S066 S067 S068 
S069 S071 S072 S074 S075 S077 S079 S080 S081 
S082 S083 S084 S088 S089 S090 S091 S092 S093 
S094 S095 S096 S097 S098 S099 S100 
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