- Device
- VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P240006
- Supplement
- S016
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-06-30
- Decision code
- APPR
- Date received
- 2026-04-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Connection Interface Unit (CIU) to be used with the TRUPULSE™ Generator, to introduce a predetermined change control plan (PCCP) (Predetermined Change Control Plan TRUPULSE™ Generator System Version 1.0) for planned hardware and software changes to the TRUPULSE™ Generator and related labeling updates