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
• Generic Name: Drug-coated peripheral transluminal angioplasty catheter
• Applicant: Medtronic Vascular, Inc.; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P190008
• Supplement Number: S025
• Date Received: 08/17/2023
• Decision Date: 09/14/2023
• Product Code: PRC
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.