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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-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
Classification Namedrug-eluting peripheral transluminal angioplasty catheter
Applicant MEDTRONIC INC.
PMA NumberP140010
Supplement NumberS002
Date Received01/26/2015
Decision Date06/19/2015
Product Code
ONU[ Registered Establishments with ONU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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