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: EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Biosense Webster, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P040036
• Supplement Number: S086
• Date Received: 08/23/2021
• Decision Date: 09/22/2021
• Product Code: LPB
• 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 to add an alternate sterilization site.