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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, coronary, atherectomy
Generic Namerotational angioplasty system; atherectomy
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP900056
Date Received08/28/1990
Decision Date05/28/1993
Product Code
MCX[ Registered Establishments with MCX ]
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 
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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 S121 S122 
S123 S124 S125 S126 S127 S128 S129 S130 S131 
S132 S133 S134 S135 S136 S137 S138 S140 S142 
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