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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 SLIDING RAIL PTCA CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS053
Date Received10/24/1997
Decision Date11/21/1997
Withdrawal Date04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a 3 and 1/2 year shelf life for the Bonnie(TM) Slidng Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.
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