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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 NameCUTTING BALLOON
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty catheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
PMA NumberP950020
Supplement NumberS001
Date Received10/17/2000
Decision Date11/21/2000
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 for a modification to the distal tip of the cutting balloon(tm).
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