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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 TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
Classification Namedrug-eluting peripheral transluminal angioplasty catheter
ApplicantMEDTRONIC, PLC
PMA NumberP140010
Supplement NumberS006
Date Received04/21/2015
Decision Date06/24/2015
Product Code
ONU[ Registered Establishments with ONU ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an extension of the shelf life of the product from 12 to 24 months.
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