Zephyr Endobronchial Valve (Zephyr Valve)

FDA Premarket Approval P180002 S019

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for modifications to your 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

DeviceZephyr Endobronchial Valve (Zephyr Valve)
Generic NameValve, Pulmonary
ApplicantPulmonx Corporation
Date Received2021-07-16
Decision Date2021-08-13
PMAP180002
SupplementS019
Product CodeNJK 
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Pulmonx Corporation 700 Chesapeake Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P180002Original Filing
S020 2022-02-07 Normal 180 Day Track No User Fee
S019 2021-07-16 Normal 180 Day Track No User Fee
S018
S017 2020-10-23 30-day Notice
S016 2020-09-30 30-day Notice
S015 2019-12-19 135 Review Track For 30-day Notice
S014 2019-11-08 30-day Notice
S013 2019-10-25 30-day Notice
S012 2019-10-24 30-day Notice
S011
S010 2019-08-19 Real-time Process
S009 2019-08-05 Normal 180 Day Track No User Fee
S008 2019-06-17 30-day Notice
S007
S006 2019-02-15 135 Review Track For 30-day Notice
S005
S004 2018-11-29 Normal 180 Day Track No User Fee
S003
S002 2018-07-27 Normal 180 Day Track No User Fee
S001 2018-07-09 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00811907030720 P180002 000
00811907030621 P180002 000
00811907030522 P180002 000
00811907030324 P180002 000
00811907030225 P180002 000
00811907030126 P180002 000
00811907031222 P180002 005
00811907030423 P180002 005

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