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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP140010
Supplement NumberS006
Date Received04/21/2015
Decision Date06/24/2015
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE PRODUCT FROM 12 TO 24 MONTHS.
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