Zephyr Endobronchial Valve (EBV) System

FDA Premarket Approval P180002 S015

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

For a manufacturing change with the existing approved supplier confluent medical (fremont, ca) for the nitinol retainer component of the zephyr 4. 0 ebv.

DeviceZephyr Endobronchial Valve (EBV) System
Generic NameValve, Pulmonary
ApplicantPulmonx Corporation
Date Received2019-12-19
Decision Date2020-10-06
PMAP180002
SupplementS015
Product CodeNJK 
Advisory CommitteeAnesthesiology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Pulmonx Corporation 700 Chesapeake Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P180002Original Filing
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
00811907030126 P180002 000
00811907030225 P180002 000
00811907030324 P180002 000
00811907030522 P180002 000
00811907030621 P180002 000
00811907030720 P180002 000
00811907030126 P180002 000
00811907030225 P180002 000
00811907030324 P180002 000
00811907030522 P180002 000
00811907030621 P180002 000
00811907031222 P180002 005
00811907030423 P180002 005

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