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 ABLATION CATHETER
• 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: S011
• Date Received: 10/30/2015
• Decision Date: 02/24/2016
• Product Code: OAE
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a manufacturing site located at Sterigenics, in Willowbrook, Illinois.