PMA P950005S067
- Device
- WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S067
- Product code
- LPB
- Decision date
- 2017-10-10
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Transfer of the extrusion process of the Braided Dual Lumen and Braided Triple Lumen subcomponent catheter part.
Current openFDA PMA Record#
- Device
- WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S067
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-10-10
- Decision code
- OK30
- Date received
- 2017-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the extrusion process of the Braided Dual Lumen and Braided Triple Lumen subcomponent catheter part.