P950005S027

None

FDA Premarket Approval P950005 S027

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

DeviceP950005S027
Classification NameNone
Applicant
PMAP950005
SupplementS027

Supplemental Filings

Supplement NumberDateSupplement Type
P950005Original Filing
S085 2022-09-02 30-day Notice
S084 2022-06-10 Normal 180 Day Track
S083 2021-08-23 Normal 180 Day Track No User Fee
S082
S081 2021-06-11 30-day Notice
S080
S079 2021-04-12 30-day Notice
S078 2021-03-31 30-day Notice
S077 2021-03-02 Special (immediate Track)
S076 2021-01-28 30-day Notice
S075 2020-09-15 30-day Notice
S074 2020-03-13 30-day Notice
S073 2020-01-16 30-day Notice
S072 2019-07-30 30-day Notice
S071 2019-02-12 30-day Notice
S070 2018-07-02 30-day Notice
S069 2017-11-27 135 Review Track For 30-day Notice
S068 2017-10-03 30-day Notice
S067 2017-09-11 30-day Notice
S066 2017-06-30 30-day Notice
S065 2017-06-29 30-day Notice
S064 2017-06-02 135 Review Track For 30-day Notice
S063 2016-11-28 135 Review Track For 30-day Notice
S062 2016-08-26 30-day Notice
S061 2016-06-13 Normal 180 Day Track
S060 2016-03-31 30-day Notice
S059 2015-10-09 30-day Notice
S058 2015-07-17 30-day Notice
S057 2015-05-06 30-day Notice
S056 2015-02-20 30-day Notice
S055 2014-11-14 30-day Notice
S054 2014-09-29 Real-time Process
S053 2014-09-22 30-day Notice
S052 2014-08-14 30-day Notice
S051 2014-07-02 Normal 180 Day Track No User Fee
S050 2014-04-03 135 Review Track For 30-day Notice
S049 2013-12-27 30-day Notice
S048 2013-10-18 30-day Notice
S047 2013-11-01 Real-time Process
S046 2013-09-13 30-day Notice
S045 2013-08-09 30-day Notice
S044 2013-04-26 30-day Notice
S043 2013-03-27 30-day Notice
S042 2013-03-21 135 Review Track For 30-day Notice
S041 2012-11-07 Normal 180 Day Track
S040 2012-09-25 30-day Notice
S039 2012-06-19 30-day Notice
S038 2012-06-19 Normal 180 Day Track
S037 2012-04-16 Normal 180 Day Track
S036 2011-11-21 30-day Notice
S035 2011-08-29 30-day Notice
S034 2011-03-01 30-day Notice
S033 2011-03-01 135 Review Track For 30-day Notice
S032 2011-01-31 30-day Notice
S031 2010-10-27 Normal 180 Day Track No User Fee
S030 2010-03-02 Normal 180 Day Track No User Fee
S029 2010-02-12 30-day Notice
S028 2009-09-28 Real-time Process
S027
S026 2009-04-15 30-day Notice
S025 2009-02-18 Normal 180 Day Track
S024 2007-12-14 Normal 180 Day Track No User Fee
S023 2007-10-04 30-day Notice
S022 2007-09-28 Real-time Process
S021 2007-07-24 30-day Notice
S020 2006-01-26 30-day Notice
S019 2005-09-06 Normal 180 Day Track
S018 2004-09-28 Normal 180 Day Track
S017 2003-01-02 Real-time Process
S016 2002-06-07 Real-time Process
S015 2002-04-17 Normal 180 Day Track
S014 2001-05-29 Normal 180 Day Track
S013 2001-05-23 Real-time Process
S012 2001-04-13 Normal 180 Day Track
S011 2001-02-21 Normal 180 Day Track
S010 2000-12-08 Normal 180 Day Track
S009 2000-07-31 Normal 180 Day Track
S008 2000-04-19 Normal 180 Day Track
S007 1999-11-26 Real-time Process
S006 1999-08-02
S005
S004 1999-02-22 Real-time Process
S003 1998-07-27 Normal 180 Day Track
S002 1998-03-23 Normal 180 Day Track
S001 1997-11-10 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10846835006070 P950005 000
10846835000368 P950005 000
10846835000375 P950005 000
10846835000382 P950005 000
10846835005608 P950005 000
10846835004618 P950005 000
10846835004625 P950005 000
10846835004632 P950005 000
10846835004649 P950005 000
10846835004663 P950005 000
10846835004670 P950005 000
10846835005554 P950005 000
10846835006100 P950005 000
10846835005660 P950005 000
10846835006087 P950005 000
10846835006063 P950005 000
10846835006117 P950005 000
10846835006131 P950005 000
10846835006155 P950005 000
10846835006162 P950005 000
10846835006179 P950005 000
10846835006018 P950005 000
10846835005912 P950005 000
10846835005714 P950005 000
10846835005684 P950005 000
10846835005530 P950005 000
10846835005592 P950005 000
10846835003895 P950005 000
10846835004656 P950005 000
10846835005080 P950005 000
10846835005110 P950005 000
10846835004694 P950005 000
10846835004465 P950005 000
10846835004427 P950005 000
10846835004403 P950005 000
10846835004373 P950005 000
10846835001662 P950005 000
10846835005073 P950005 000
10846835000405 P950005 000
10846835000719 P950005 000
10846835004731 P950005 001
10846835004588 P950005 001
10846835004724 P950005 001
10846835004717 P950005 001
10846835006209 P950005 001
10846835006247 P950005 001
10846835004601 P950005 001
10846835006056 P950005 001
10846835000412 P950005 001
10846835000429 P950005 001
10846835006032 P950005 001
10846835001839 P950005 002
10846835005479 P950005 002
10846835005455 P950005 002
10846835005448 P950005 002
10846835005431 P950005 002
10846835005400 P950005 002
10846835005349 P950005 002
10846835005486 P950005 002
10846835005318 P950005 002
10846835005196 P950005 002
10846835005141 P950005 002
10846835005516 P950005 002
10846835006681 P950005 002
10846835006452 P950005 002
10846835006476 P950005 002
10846835006513 P950005 002
10846835006520 P950005 002
10846835006551 P950005 002
10846835006575 P950005 002
10846835006599 P950005 002
10846835006605 P950005 002
10846835006612 P950005 002
10846835006636 P950005 002
10846835006643 P950005 002
10846835006667 P950005 002
10846835006674 P950005 002
10846835005370 P950005 002
10846835006506 P950005 002
10846835005219 P950005 002
10846835000436 P950005 002
10846835006421 P950005 002
10846835006414 P950005 002
10846835006216 P950005 002
10846835006292 P950005 002
10846835005493 P950005 002
10846835006322 P950005 002
10846835005233 P950005 002
10846835006384 P950005 002
10846835005257 P950005 002
10846835006353 P950005 002
10846835005172 P950005 002
10846835005301 P950005 004
10846835005165 P950005 004
10846835005356 P950005 004
10846835005417 P950005 004
10846835006469 P950005 004
10846835005264 P950005 004
10846835005240 P950005 004
10846835005202 P950005 004
10846835006483 P950005 004
10846835005189 P950005 004
10846835003888 P950005 018
10846835002539 P950005 019
10846835002485 P950005 019
10846835002508 P950005 019
10846835002515 P950005 019
10846835002553 P950005 019
10846835002577 P950005 019
10846835002751 P950005 019
10846835002720 P950005 019
10846835002706 P950005 019
10846835002676 P950005 019
10846835002652 P950005 019
10846835002645 P950005 019
10846835002621 P950005 019
10846835002607 P950005 019
10846835002584 P950005 019
10846835013085 P950005 041
10846835005226 P950005 056

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.