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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 AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantMedtronic Vascular, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP190008
Supplement NumberS013
Date Received03/04/2021
Decision Date03/12/2021
Product Code PRC 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.
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