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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 SCIENTIFIC/SCIMED PTCA/PERFUSION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS185
Date Received06/05/2002
Decision Date06/25/2002
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 the inclusion of a table specifying the recommended minimum guiding catheter inner diameter in the instructions for use (ifu) for the following ptca catheter models: nc monorail, nc ranger 15 mm, nc ranger 22/25/30 mm, nc ranger 16/18 mm and nc ranger 9 mm.
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