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, Livewire TC Cables, Safire Ablation Catheter, Safire Cables
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: St. Jude Medical; 14900 MINNETONKA IND RD; MINNETONKA, MN 55345
• PMA Number: P960016
• Supplement Number: S085
• Date Received: 09/18/2020
• Decision Date: 10/16/2020
• 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

Approval Order Statement  
Alternative batch sampling for bacterial endotoxin testing.