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: TactiCath Quartz Set
• Generic Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Applicant: St Jude Medical; One St. Jude Medical Dr.; St. Paul, MN 55117
• PMA Number: P130026
• Supplement Number: S029
• Date Received: 02/05/2018
• Decision Date: 03/06/2018
• Product Code: OAE
• 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  
Alternative Electrical Safety Test for the Ampere Generator, Ampere Remote Control and TactiSys Quartz Equipment.