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: Livewire TC Ablation Catheter
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: St Jude Medical; 14900 Minnetonka Ind Rd.; Minnetonka, MN 55345
• PMA Number: P960016
• Supplement Number: S075
• Date Received: 08/02/2018
• Decision Date: 08/28/2018
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
removal of a wire crimp visual inspection step within the handle assembly