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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 NameNC BIG RANGER PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty catheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS192
Date Received11/25/2002
Decision Date12/17/2002
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the labeling to extend the balloon compliance chart diameters to hundredths and to add a note to the directions for use stating the recommended minimum guide catheter lumen inner diameter.
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