PMA P250022
- Device
- Volt™ PFA System
- Applicant
- ABBOTT MEDICAL
- Product code
- QZI
- Decision date
- 2026-04-16
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- firmware maintenance update for the generator and additional accessory cable
Current openFDA PMA Record#
- Device
- Volt™ PFA System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P250022
- Supplement
- S003
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-04-16
- Decision code
- APPR
- Date received
- 2026-01-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- firmware maintenance update for the generator and additional accessory cable