P020018S054

None

FDA Premarket Approval P020018 S054

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

DeviceP020018S054
Classification NameNone
Applicant
PMAP020018
SupplementS054

Supplemental Filings

Supplement NumberDateSupplement Type
P020018Original Filing
S060 2021-07-23 Normal 180 Day Track No User Fee
S059 2020-09-17 Special (immediate Track)
S058 2018-06-22 Special (immediate Track)
S057 2016-11-09 Special (immediate Track)
S056 2016-05-04 Special (immediate Track)
S055 2014-11-03 Real-time Process
S054
S053 2014-09-22 30-day Notice
S052 2014-05-06 Special (immediate Track)
S051
S050 2014-02-11 Normal 180 Day Track No User Fee
S049 2013-03-26 Special (immediate Track)
S048 2013-03-18 Normal 180 Day Track No User Fee
S047 2012-11-13 30-day Notice
S046 2012-07-26 Normal 180 Day Track
S045 2012-06-28 Special (immediate Track)
S044 2012-05-04 Normal 180 Day Track No User Fee
S043 2012-05-04 Normal 180 Day Track No User Fee
S042 2012-01-10 Normal 180 Day Track
S041 2011-10-11 Normal 180 Day Track
S040 2011-10-07 Panel Track
S039 2011-06-23 Normal 180 Day Track No User Fee
S038 2011-05-03 30-day Notice
S037 2010-08-30 Normal 180 Day Track
S036 2010-06-18 30-day Notice
S035
S034 2010-03-10 Special (immediate Track)
S033 2009-06-04 Real-time Process
S032 2009-02-23 Normal 180 Day Track
S031 2009-02-02 Special (immediate Track)
S030 2008-11-24 30-day Notice
S029 2008-08-15 135 Review Track For 30-day Notice
S028
S027 2008-05-09 Special (immediate Track)
S026 2008-03-03 Normal 180 Day Track
S025 2008-01-22 135 Review Track For 30-day Notice
S024 2007-05-01 Normal 180 Day Track
S023 2007-02-21 Normal 180 Day Track No User Fee
S022 2006-11-13 135 Review Track For 30-day Notice
S021 2006-11-06 30-day Notice
S020 2006-11-06 30-day Notice
S019 2006-11-06 30-day Notice
S018 2006-10-05 30-day Notice
S017 2006-10-04 30-day Notice
S016 2006-09-18 135 Review Track For 30-day Notice
S015 2006-09-18 30-day Notice
S014 2006-09-18 30-day Notice
S013 2006-09-18 30-day Notice
S012
S011 2006-09-18 135 Review Track For 30-day Notice
S010 2006-06-02 Normal 180 Day Track
S009 2006-05-01 Special (immediate Track)
S008 2006-01-09 Special (immediate Track)
S007 2005-10-17 Normal 180 Day Track No User Fee
S006 2005-05-19 30-day Notice
S005 2005-01-03 Normal 180 Day Track
S004 2004-05-11 Normal 180 Day Track
S003 2003-12-22 Normal 180 Day Track
S002 2003-10-06 Normal 180 Day Track
S001 2003-09-22 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
10827002325453 P020018 040
10827002325323 P020018 040
10827002325316 P020018 040
10827002325309 P020018 040
10827002325293 P020018 040
10827002325286 P020018 040
10827002325279 P020018 040
10827002325262 P020018 040
10827002325255 P020018 040
10827002325248 P020018 040
10827002325330 P020018 040
10827002325347 P020018 040
10827002325354 P020018 040
10827002325446 P020018 040
10827002325439 P020018 040
10827002325422 P020018 040
10827002325415 P020018 040
10827002325408 P020018 040
10827002325392 P020018 040
10827002325385 P020018 040
10827002325378 P020018 040
10827002325361 P020018 040
10827002325231 P020018 040
10827002325224 P020018 040
10827002325095 P020018 040
10827002325088 P020018 040
10827002325071 P020018 040
10827002325064 P020018 040
10827002325057 P020018 040
10827002325040 P020018 040
10827002325033 P020018 040
10827002325026 P020018 040
10827002325019 P020018 040
10827002325101 P020018 040
10827002325118 P020018 040
10827002325125 P020018 040
10827002325217 P020018 040
10827002325200 P020018 040
10827002325194 P020018 040
10827002325187 P020018 040
10827002325170 P020018 040
10827002325163 P020018 040
10827002325156 P020018 040
10827002325149 P020018 040
10827002325132 P020018 040
10827002325002 P020018 040
10827002325460 P020018 040
10827002325927 P020018 040
10827002325798 P020018 040
10827002325781 P020018 040
10827002325774 P020018 040
10827002325767 P020018 040
10827002325750 P020018 040
10827002325743 P020018 040
10827002325736 P020018 040
10827002325729 P020018 040
10827002325712 P020018 040
10827002325804 P020018 040
10827002325811 P020018 040
10827002325828 P020018 040
10827002325910 P020018 040
10827002325903 P020018 040
10827002325897 P020018 040
10827002325880 P020018 040
10827002325873 P020018 040
10827002325866 P020018 040
10827002325859 P020018 040
10827002325842 P020018 040
10827002325835 P020018 040
10827002325705 P020018 040
10827002325699 P020018 040
10827002325569 P020018 040
10827002325552 P020018 040
10827002325545 P020018 040
10827002325538 P020018 040
10827002325521 P020018 040
10827002325514 P020018 040
10827002325507 P020018 040
10827002325491 P020018 040
10827002325484 P020018 040
10827002325576 P020018 040
10827002325583 P020018 040
10827002325590 P020018 040
10827002325682 P020018 040
10827002325675 P020018 040
10827002325668 P020018 040
10827002325651 P020018 040
10827002325644 P020018 040
10827002325637 P020018 040
10827002325620 P020018 040
10827002325613 P020018 040
10827002325606 P020018 040
10827002325477 P020018 040

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