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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 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP140010
Supplement NumberS106
Date Received09/04/2026
Decision Date09/24/2026
Product Code ONU 
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  
approval for a change to the in-process testing strategy and sample size for balloon burst testing, proximal weld tensile strength testing, and distal tip weld tensile of the IN.PACT DCB 018 catheter
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