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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCUTTING BALLOON
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP950020
Supplement NumberS003
Date Received08/20/2001
Decision Date01/23/2002
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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