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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 (PTA) Balloon Catheter
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantMedtronic Vascular, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP190008
Supplement NumberS005
Date Received08/12/2020
Decision Date09/11/2020
Product Code PRC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the analysis plan and case report forms for the New Enrollment IN.PACT AV Access PAS.
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