PMA P250022S012
- Device
- VOLT™ PFA CATHETER, SENSOR ENABLED™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P250022
- Supplement
- S012
- Product code
- QZI
- Decision date
- 2026-10-08
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- Supplier and manufacturing process change for catheter delivery tool
Current openFDA PMA Record#
- Device
- VOLT™ PFA CATHETER, SENSOR ENABLED™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P250022
- Supplement
- S012
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-10-08
- Decision code
- OK30
- Date received
- 2026-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier and manufacturing process change for catheter delivery tool