PMA P180002S028

Device: Zephyr Endobronchial Valve (EBV) System
Applicant: Pulmonx Corporation
PMA number: P180002
Supplement: S028
Product code: NJK
Decision date: 2024-08-23
Classification: Anesthesiology
Generic name: Valve, pulmonary
Approval order statement: A manufacturing change from two cycles of ethylene oxide (EO) sterilization to three cycles of ethylene oxide sterilization with a three-year shelf life for two lots of the Zephyr 4.0-LP EBV (Lot 506377-V7.1 and Lot 506412-V7.1).

Current openFDA PMA Record#

Device: Zephyr Endobronchial Valve (EBV) System
Applicant: Pulmonx Corporation
PMA number: P180002
Supplement: S028
Product code: NJK
Generic name: Valve, pulmonary
Decision date: 2024-08-23
Decision code: OK30
Date received: 2024-07-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: A manufacturing change from two cycles of ethylene oxide (EO) sterilization to three cycles of ethylene oxide sterilization with a three-year shelf life for two lots of the Zephyr 4.0-LP EBV (Lot 506377-V7.1 and Lot 506412-V7.1).