PMA P040014
- Device
- Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S047
- Product code
- LPB
- Decision date
- 2026-09-03
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- to add an alternate epoxy in the manufacture of the temperature sensor
Current openFDA PMA Record#
- Device
- Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S052
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2026-09-03
- Decision code
- OK30
- Date received
- 2026-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternate epoxy in the manufacture of the temperature sensor