P180002S005

None

FDA Premarket Approval P180002 S005

This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.

Pre-market Approval Supplement Details

DeviceP180002S005
Classification NameNone
Applicant
PMAP180002
SupplementS005

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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