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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.
 
DeviceCUTTING BALLOON
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
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 change design/components/specifications/material
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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