PMA P040014S042
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S042
- Product code
- LPB
- Decision date
- 2021-03-12
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.
Current openFDA PMA Record#
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S042
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-03-12
- Decision code
- APPR
- Date received
- 2021-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to a printed circuit board assembly and a change in supplier for the manufacture of the printed circuit board assembly.