PMA P250022
- Device
- Volt™ PFA System
- Applicant
- ABBOTT MEDICAL
- Product code
- QZI
- Decision date
- 2026-07-10
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- approval for additional manufacturing activities at Minnetonka, Minnesota
Current openFDA PMA Record#
- Device
- Volt™ PFA System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P250022
- Supplement
- S006
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-07-10
- Decision code
- APPR
- Date received
- 2026-05-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for additional manufacturing activities at Minnetonka, Minnesota