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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.
 
DeviceFLEXATOME CUTTING BALLOON
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP950020
Date Received06/26/1995
Decision Date04/18/2000
Product Code NWX 
Docket Number 00M-1298
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
THIS DEVICE IS INDICATED FOR THE DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED. IN ADDITION, THE TARGET LESION SHOULD POSSESS THE FILLOWING CHARACTERISTICS: DISCRETE (<=15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S046  S042 S044 S045 S068 S069 S057 S058 S059 S071 S066 
S049 S011 S012 S009 S002 S015 S005 S006 S020 S021 S022 S023 
S037 S038 S031 S032 S019 S008 S014 S018 S010 S073 S079 S080 
S001 S047 S048 S064 S065 S067 S060 S052 S053 S054 S050 S051 
S063 S055 S056 S061 S007 S013 S016 S017 S003 S004 S026 S034 
S039 S040 S035 S030 S024 S025 S027 S029 S036 S072 S081 S076 
S077 S078 S075 S090 S084 S086 S087 S107 S096 S097 S109 S121 
S122 S130 S131 S132 S133 S134 S112 S113 S114 S137 S138 S082 
S083 S089 S088 S092 S108 S093 S094 S095 S099 S100 S101 S102 
S103 S104 S105 S106 S098 S091 S125 S126 S127 S116 S117 S135 
S136 S128 S129 S123 S124 S110 S111 S118 S120 S115 S142 S139 
S140 S141 
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