Premarket Approval (PMA)

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.

• Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
• Generic Name: Drug-coated peripheral transluminal angioplasty catheter
• Applicant: Medtronic Vascular, Inc.; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P190008
• Supplement Number: S024
• Date Received: 05/15/2023
• Decision Date: 05/22/2023
• Product Code: PRC
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Changes to the welding process of the catheter subassembly of the IN.PACT Admiral PTA DCB.