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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 (TM) PTCA CATHERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC
One Scimed Place
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS052
Date Received09/09/1997
Decision Date08/27/1998
Withdrawal Date 04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new PTCA catheter. The device, as modified, will be marketed under the trade name Bypass Speedy(TM) Monorail(R) PTCA Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpsoe of improving myocardial perfusion.
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