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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCUTTING BALLOON MONORAIL
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
PMA NumberP950020
Supplement NumberS004
Date Received09/17/2001
Decision Date02/15/2002
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a rapid exchange version of the cutting balloon. The device, as modified, will be marketed under the trade name cutting balloon monorail and is indicated for dilatation of stenosis 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 posses the following 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 antiographic contour; and absence of angiographically-visible thrombus and/or calcification.
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