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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 NumberS003
Date Received08/20/2001
Decision Date01/23/2002
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications to the device: 1) modification of the design and materials of construction of the y-site assembly; 2) use of a colorant in the guidewire lumen tubing; 3) new packaging configuration and materials; and 4) use of an alternative sterilizer.
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