PMA P030031S117
- Device
- EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THERMOCOOL NAV
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S117
- Product code
- OAD
- Decision date
- 2021-04-27
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Procedure to repackage and relabel products with secondary packaging damage.
Current openFDA PMA Record#
- Device
- EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THERMOCOOL NAV
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S117
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-04-27
- Decision code
- OK30
- Date received
- 2021-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Procedure to repackage and relabel products with secondary packaging damage.