PMA P010068S045
- Device
- EZ STEER NAV DS BI-DIRECTIONAL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S045
- Product code
- OAD
- Decision date
- 2015-03-19
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
Current openFDA PMA Record#
- Device
- EZ STEER NAV DS BI-DIRECTIONAL CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S045
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-03-19
- Decision code
- OK30
- Date received
- 2015-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.