Zephyr 5.5 EBV Circle Flange Valve

Valve, Pulmonary

FDA Premarket Approval P180002 S010

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 the zephyr 5. 5 ebv circle flange valve.

DeviceZephyr 5.5 EBV Circle Flange Valve
Classification NameValve, Pulmonary
Generic NameValve, Pulmonary
ApplicantPulmonx Corporation
Date Received2019-08-19
Decision Date2019-11-13
PMAP180002
SupplementS010
Product CodeNJK
Advisory CommitteeAnesthesiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Pulmonx Corporation 700 Chesapeake Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P180002Original Filing
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
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
00811907030126 P180002 000

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