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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 NumberS035
Date Received10/29/2024
Decision Date11/22/2024
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  
a modified reserve sampling approach for the IN.PACT AV DCB and IN.PACT 018 DCB, and a modified sampling plan for the IN.PACT 018 DCB drug content uniformity testing at lot release
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