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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 NamePTCA CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS157
Date Received10/06/1999
Decision Date11/03/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested an alternate manufacturing method of attaching the proximal shaft to t he core wire sub-assembly on the following ptca catheters: viva(tm) p860019/s143; maxxum(tm) p860019/s144; nc maxxum(tm) p860019/s150; adante(tm) p860019/s154.
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