PMA P010068S038
- Device
- NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S038
- Product code
- OAD
- Decision date
- 2014-01-24
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
Current openFDA PMA Record#
- Device
- NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S038
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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.