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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 NameROTABLATOR(R)
Classification Namecatheter, peripheral, atherectomy
Generic Namerotational angioplasty system; atherectomy
Regulation Number870.4875
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Date Received08/28/1990
Decision Date05/28/1993
Product Code
MCW[ Registered Establishments with MCW ]
Docket Number 93M-0208
Notice Date 07/16/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S008 S009 S010 S011 S012 S014 
S015 S016 S017 S018 S019 S020 
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S027 S028 S029 S030 S031 S032 
S033 S034 S035 S036 S037 S038 
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 S065 S066 S067 S068 
S069 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 
S081 S082 S083 S084 S086 S088 
S089 S090 S091 S092 S093 S094 
S095 S096 S097 S098 S099 S100 
S101 S102 S103 S104 S106 S107 
S108 S109 S110 S111 S112 S113 
S114 S115 S116 S117 S118 S119 
S120 
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