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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 NameFLEXATOME CUTTING BALLOON
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namepercutaneous transluminal coronary angioplasty catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP950020
Date Received06/26/1995
Decision Date04/18/2000
Product Code
NWX[ Registered Establishments with NWX ]
Docket Number 00M-1298
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
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 
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