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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
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
PMA NumberP950020
Supplement NumberS006
Date Received06/28/2002
Decision Date03/11/2003
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: 1) use of the bioslide coating on all cutting balloon models, and 2) use of a revised y-site on over-the-wire (otw) cutting balloon models. The device, as modified, will be marketed under the trade name cutting balloon monorail/otw and is indicated for 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 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 angiographic contour; and absence of angiographically-visible thrombus and/or calcification.
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