PMA P950005S084
- Device
- CELSIUS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S084
- Product code
- LPB
- Decision date
- 2022-09-09
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for software and hardware modifications for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR, and CELSIUS catheters).
Current openFDA PMA Record#
- Device
- CELSIUS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S084
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2022-09-09
- Decision code
- APPR
- Date received
- 2022-06-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software and hardware modifications for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR, and CELSIUS catheters).