Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S029 S030 S031 S032 S034 S035 S036 S037 
S038 S039 S040 S042 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S063 S064 
S065 S066 S067 S068 S069 S071 S072 S073 S075 S076 S077 S078 
S079 S080 S081 S082 S083 S084 S086 S087 S088 S089 S090 S091 
S092 S093 S094 S095 S096 S097 S098 S099 S100 S101 S102 S103 
S104 S105 S106 S107 S108 S109 S110 S111 S112 S113 S114 S115 
S116 S117 S118 S120 S121 S122 S123 S124 S125 S126 S127 S128 
S129 S130 S131 S132 S133 S134 S135 S136 S137 S138 S139 S140 
S141 S142 
-
-