PMA P950005S070
- Device
- Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S070
- Product code
- LPB
- Decision date
- 2018-07-30
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Addition of a new sealer for the sterile pouch.
Current openFDA PMA Record#
- Device
- Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S070
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2018-07-30
- Decision code
- OK30
- Date received
- 2018-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new sealer for the sterile pouch.