PMA P240006S020
- Device
- VARIPULSE BI-DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P240006
- Supplement
- S020
- Product code
- QZI
- Decision date
- 2026-09-15
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- an additional supplier for critical components
Current openFDA PMA Record#
- Device
- VARIPULSE BI-DIRECTIONAL CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P240006
- Supplement
- S020
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-09-15
- Decision code
- OK30
- Date received
- 2026-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier for critical components