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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 NameIN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER
Classification Namedrug-eluting peripheral transluminal angioplasty catheter
Applicant MEDTRONIC INC.
PMA NumberP140010
Supplement NumberS004
Date Received03/18/2015
Decision Date04/06/2015
Product Code
ONU[ Registered Establishments with ONU ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
The addition of a new cleanroom for a coating procedure as well as the relocation of the outer packing process.
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