PMA P990025S036

Device: NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S036
Product code: LPB
Decision date: 2013-04-25
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.

Current openFDA PMA Record#

Device: NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S036
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2013-04-25
Decision code: OK30
Date received: 2013-03-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.