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 ADMIRAL PACLITAXEL BALLOON CATHETER
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: Medtronic, Inc.; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P140010
• Supplement Number: S028
• Date Received: 01/12/2017
• Decision Date: 01/26/2017
• Product Code: ONU
• 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  
Minor modifications to the incoming inspection of the active pharmaceutical ingredient to include expiry dates of the solutions.