PMA P010068S035
- Device
- CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER,
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S035
- Product code
- OAD
- Decision date
- 2013-09-05
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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
- CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER,
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S035
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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.