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 DCB
• Generic Name: Drug-coated peripheral transluminal angioplasty catheter
• Applicant: Medtronic Vascular, Inc.; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P190008
• Supplement Number: S014
• Date Received: 04/23/2021
• Decision Date: 05/21/2021
• Product Code: PRC
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.