PMA P180002S019

Device: Zephyr Endobronchial Valve (Zephyr Valve)
Applicant: Pulmonx Corporation
PMA number: P180002
Supplement: S019
Product code: NJK
Decision date: 2021-08-13
Generic name: Valve, pulmonary
Approval order statement: Approval for modifications to the protocol to include collection of perfusion data at baseline, extension of high-resolution computed tomography (HRCT) baseline data collection window from 3 months to 6 months prior to Informed Consent date, and collection of HRCT data at 12 months.

Current openFDA PMA Record#

Device: Zephyr Endobronchial Valve (Zephyr Valve)
Applicant: Pulmonx Corporation
PMA number: P180002
Supplement: S019
Product code: NJK
Generic name: Valve, pulmonary
Decision date: 2021-08-13
Decision code: APPR
Date received: 2021-07-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for modifications to the protocol to include collection of perfusion data at baseline, extension of high-resolution computed tomography (HRCT) baseline data collection window from 3 months to 6 months prior to Informed Consent date, and collection of HRCT data at 12 months.