- Device
- Ampere Generator
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S059
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-08-07
- Decision code
- APPR
- Date received
- 2026-05-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for firmware changes to the TactiSys Quartz Equipment v1.8.0 and Ampere Generator v1.2.0 to maintain compatibility with the TactiFlex Duo Ablation Catheter, Sensor Enabled™