PMA P950005S049

Device: CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S049
Product code: LPB
Decision date: 2014-01-24
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.

Current openFDA PMA Record#

Device: CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S049
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-01-24
Decision code: OK30
Date received: 2013-12-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.