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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 NameBOSTON SCINTIFIC SCIMED PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP880027
Supplement NumberS060
Date Received07/12/2001
Decision Date07/30/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the warning statement in the directions for use manual to expand on the potential affect of re-processing or re-sterilization.
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