P080013S019

None

FDA Premarket Approval P080013 S019

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

DeviceP080013S019
Classification NameNone
Applicant
PMAP080013
SupplementS019

Supplemental Filings

Supplement NumberDateSupplement Type
P080013Original Filing
S020 2020-06-23 Special (immediate Track)
S019
S018 2019-12-30 Normal 180 Day Track No User Fee
S017 2019-06-11 30-day Notice
S016 2018-10-29 30-day Notice
S015 2017-11-30 Normal 180 Day Track No User Fee
S014 2017-07-28 Normal 180 Day Track No User Fee
S013 2016-04-18 Real-time Process
S012
S011 2015-02-02 Normal 180 Day Track No User Fee
S010
S009 2013-06-04 135 Review Track For 30-day Notice
S008 2013-03-25 Normal 180 Day Track No User Fee
S007 2011-07-20 Special (immediate Track)
S006 2011-03-21 Normal 180 Day Track No User Fee
S005
S004 2011-03-02 Normal 180 Day Track No User Fee
S003 2010-01-20 Normal 180 Day Track
S002 2009-10-14 Real-time Process
S001 2009-10-06 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
30381780000048 P080013 009
30381780000031 P080013 009

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