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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 NameANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namepercutaneous transluminal coronary angioplasty catheter
ApplicantANGIOSCORE INC
PMA NumberP050018
Supplement NumberS014
Date Received04/13/2011
Decision Date05/12/2011
Product Code
NWX[ Registered Establishments with NWX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing change to include a new part number for the device and the purchase of the oem rapid exchange balloon catheter manufactured by a qualified supplier.
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