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 Equipment
• Generic Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Applicant: St. Jude Medical; One St. Jude Medical Drive; St. Paul, MN 55117
• PMA Number: P130026
• Supplement Number: S034
• Date Received: 07/02/2018
• Decision Date: 10/15/2018
• Product Code: OAE
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for TactiSys Quartz motherboard and software changes.