PMA P950005S073
- Device
- Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S073
- Product code
- LPB
- Decision date
- 2020-02-26
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Line 13 transfer and addition of new Slim Line Dryer
Current openFDA PMA Record#
- Device
- Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S073
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-02-26
- Decision code
- OK30
- Date received
- 2020-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Line 13 transfer and addition of new Slim Line Dryer