PMA P040036
- Device
- Thermocool Deflectable Diagnostic/ Ablation Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S090
- Product code
- LPB
- Decision date
- 2025-02-25
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- an alternate supplier for molded piston components
Current openFDA PMA Record#
- Device
- Thermocool Deflectable Diagnostic/ Ablation Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S100
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2025-02-25
- Decision code
- OK30
- Date received
- 2025-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate supplier for molded piston components