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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
Applicant
MEDTRONIC Inc.
3576 unocal pl
santa rosa, CA 95403
PMA NumberP140010
Supplement NumberS037
Date Received12/08/2017
Decision Date04/19/2018
Product Code ONU 
Docket Number 18M-1634
Notice Date 04/26/2018
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter. This device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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