P050010S021

None

FDA Premarket Approval P050010 S021

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

DeviceP050010S021
Classification NameNone
Applicant
PMAP050010
SupplementS021

Supplemental Filings

Supplement NumberDateSupplement Type
P050010Original Filing
S022 2019-09-09 Real-time Process
S021
S020
S019 2017-10-18 30-day Notice
S018
S017 2016-01-15 30-day Notice
S016 2014-04-03 135 Review Track For 30-day Notice
S015
S014 2012-12-07 Normal 180 Day Track
S013 2012-11-08 Normal 180 Day Track No User Fee
S012 2011-04-26 Real-time Process
S011 2011-01-28 135 Review Track For 30-day Notice
S010 2010-09-29 135 Review Track For 30-day Notice
S009 2010-09-15 135 Review Track For 30-day Notice
S008 2010-08-02 Real-time Process
S007 2010-05-19 Normal 180 Day Track No User Fee
S006 2010-04-26 30-day Notice
S005 2010-04-26 30-day Notice
S004
S003 2008-07-28 30-day Notice
S002 2008-05-29 135 Review Track For 30-day Notice
S001 2007-12-26 Real-time Process

NIH GUDID Devices

Device IDPMASupp
10705034700182 P050010 000
10705034700052 P050010 000
10705034700069 P050010 000
10705034700083 P050010 000
10705034700090 P050010 000
10705034700106 P050010 000
10705034700137 P050010 000
10705034700144 P050010 000
10705034700151 P050010 000
10705034700175 P050010 000
10705034700045 P050010 000

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