PMA P010068S060
- Device
- EZ Steer NAV DS Bi-Directional Electrophysiology Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S060
- Product code
- OAD
- Decision date
- 2020-09-24
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Implementing an alternate laser wire stripping process.
Current openFDA PMA Record#
- Device
- EZ Steer NAV DS Bi-Directional Electrophysiology Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S060
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-09-24
- Decision code
- OK30
- Date received
- 2020-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing an alternate laser wire stripping process.