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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 NumberS041
Date Received06/12/2025
Decision Date07/10/2025
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  
change to two manufacturing process changes affecting the IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty BalloonCatheter, IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter and IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty BalloonCatheter
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