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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.
 
Trade NameTRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP880027
Supplement NumberS056
Date Received11/24/1999
Decision Date01/07/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Revisions to the box and pouch labels for the bonnie ptca catheter.
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