PMA P010068S011
- Device
- NAVISTAR & EZ STEER FAMILIES OF CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S011
- Product code
- OAD
- Decision date
- 2007-10-29
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
Current openFDA PMA Record#
- Device
- NAVISTAR & EZ STEER FAMILIES OF CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S011
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2007-10-29
- Decision code
- OK30
- Date received
- 2007-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.