P870078S048

None

FDA Premarket Approval P870078 S048

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

DeviceP870078S048
Classification NameNone
Applicant
PMAP870078
SupplementS048

Supplemental Filings

Supplement NumberDateSupplement Type
P870078Original Filing
S049 2020-11-19 30-day Notice
S048
S047 2019-09-26 Real-time Process
S046 2019-06-20 30-day Notice
S045 2019-01-29 30-day Notice
S044
S043 2018-10-01 30-day Notice
S042 2018-06-21 30-day Notice
S041 2018-04-12 30-day Notice
S040 2017-12-20 30-day Notice
S039
S038 2017-09-11 30-day Notice
S037 2017-08-14 135 Review Track For 30-day Notice
S036 2017-07-10 30-day Notice
S035 2017-02-08 30-day Notice
S034 2016-10-25 30-day Notice
S033 2016-09-22 30-day Notice
S032 2016-05-06 30-day Notice
S031 2016-01-29 Real-time Process
S030 2015-10-13 30-day Notice
S029 2014-11-07 30-day Notice
S028 2014-10-14 30-day Notice
S027 2014-08-05 30-day Notice
S026 2014-06-23 30-day Notice
S025 2014-04-23 30-day Notice
S024 2013-10-25 Real-time Process
S023 2013-09-27 30-day Notice
S022 2013-07-01 30-day Notice
S021 2013-04-02 135 Review Track For 30-day Notice
S020 2013-04-01 135 Review Track For 30-day Notice
S019 2013-04-01 30-day Notice
S018 2012-12-13 30-day Notice
S017 2012-11-19 30-day Notice
S016
S015 2012-03-23 Normal 180 Day Track
S014
S013 2010-10-21 30-day Notice
S012 2010-10-20 30-day Notice
S011 2010-10-14 30-day Notice
S010 2010-06-18 30-day Notice
S009 2010-04-30 30-day Notice
S008 2010-03-31 Normal 180 Day Track
S007 2010-01-06 30-day Notice
S006 2008-09-02 Normal 180 Day Track
S005 1999-08-31 Normal 180 Day Track
S004 1998-04-06 Normal 180 Day Track
S003 1992-12-18 Normal 180 Day Track
S002 1992-07-20 Normal 180 Day Track
S001 1989-10-13 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00613994578679 P870078 006
00681490908528 P870078 006
00681490908696 P870078 006
00681490908641 P870078 006
00681490908597 P870078 006
00681490908559 P870078 006
00681490908528 P870078 006
00681490908504 P870078 006
00681490908474 P870078 006
00681490908559 P870078 006
00681490908641 P870078 006
00681490908504 P870078 006
00681490908474 P870078 006
00613994578679 P870078 006
00613994578686 P870078 006
00613994578686 P870078 006
00681490908696 P870078 006
00613994578662 P870078 006
00613994578662 P870078 006
00681490908597 P870078 006
00613994796028 P870078 008
00613994796035 P870078 008
00613994796011 P870078 008
00613994796042 P870078 008
00613994796042 P870078 008
00613994796035 P870078 008
00613994796028 P870078 008
00613994796011 P870078 008
00643169646544 P870078 031
00643169646537 P870078 031
00643169646520 P870078 031
00643169646483 P870078 031
00643169646490 P870078 031
00643169646506 P870078 031
00643169646513 P870078 031
00643169646520 P870078 031
00643169646537 P870078 031
00643169646544 P870078 031
00643169646506 P870078 031
00643169646490 P870078 031
00643169646483 P870078 031
00643169646513 P870078 031

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