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: STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: BIOSENSE WEBSTER, INC.; 31 Technology Drive; Suite 200; Irvine, CA 92618
• PMA Number: P990071
• Supplement Number: S016
• Date Received: 01/04/2012
• Decision Date: 10/31/2012
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR UPGRADING THE EXISTING ACCESSORY COOLFLOW IRRIGATION PUMP FOR THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR FOR CARDIAC ABLATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTABLATE IRRIGATION PUMP AND SMARTABLATE TUBING SET. THE INDICATIONS ARE THAT THE SMARTABLATE IRRIGATION PUMP IS A PERISTALTIC PUMP DESIGNED TO WORK IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO DELIVER IRRIGATION SOLUTION AT SPECIFIED NOW RATES TO IRRIGATED CATHETERS (SUCH AS THE BIOSENSE WEBSTER CELSIUS THERMOCOOL CATHETERS AND NAVISTAR THERMOCOOL CATHETERS) FOR COOLING PURPOSES. THE PUMP IS USED WITH THE SMARTABLATE IRRIGATION TUBING SET THAT CONDUCTS THE IRRIGATION SOLUTION FROM AN EXTERNAL SOURCE TO THE COMPATIBLE IRRIGATED CATHETERS.