PMA P990025S038

Device: NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S038
Product code: LPB
Decision date: 2013-09-05
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.

Current openFDA PMA Record#

Device: NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S038
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2013-09-05
Decision code: OK30
Date received: 2013-08-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.