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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.
 
DeviceBONNIE & BYPASS SPEEDY PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC
One Scimed Place
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS059
Date Received06/04/2001
Decision Date06/21/2001
Withdrawal Date 04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS OF THE MANIFOLD COMPONENT OF THE BONNIE AND BYPASS SPEEDY PTCA CATHETERS.
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