PMA P040014S040
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- Product code
- LPB
- Decision date
- 2020-11-02
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for software and cybersecurity updates to the Ampere Ablation Generator.
Current openFDA PMA Record#
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S040
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-11-02
- Decision code
- APPR
- Date received
- 2020-07-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software and cybersecurity updates to the Ampere Ablation Generator.