GEL-ONE

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P080020

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the gel-one. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (nsaids) or analgesics, e. G. , acetaminophen.

DeviceGEL-ONE
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSEIKAGAKU CORP.
Date Received2008-07-31
Decision Date2011-03-22
Notice Date2011-03-31
PMAP080020
SupplementS
Product CodeMOZ
Docket Number11M-0198
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address SEIKAGAKU CORP. 6-1, Marunouchi 1-chome, chiyoda-ku tokyo 100-0-0005
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P080020Original Filing
S051 2022-12-08 30-day Notice
S050
S049 2022-09-20 30-day Notice
S048 2022-06-22 30-day Notice
S047 2022-03-03 30-day Notice
S046 2021-10-27 30-day Notice
S045 2021-09-15 30-day Notice
S044 2021-07-22 30-day Notice
S043 2021-04-29 30-day Notice
S042 2021-03-18 30-day Notice
S041
S040 2020-10-20 30-day Notice
S039 2020-10-14 30-day Notice
S038 2020-07-01 30-day Notice
S037 2020-03-10 30-day Notice
S036 2020-02-25 30-day Notice
S035 2019-08-01 Real-time Process
S034
S033 2019-02-07 30-day Notice
S032 2019-02-05 30-day Notice
S031 2018-11-07 30-day Notice
S030 2018-07-12 30-day Notice
S029 2018-02-14 30-day Notice
S028 2018-01-10 30-day Notice
S027 2017-11-15 30-day Notice
S026 2017-06-28 135 Review Track For 30-day Notice
S025 2017-02-23 30-day Notice
S024 2016-12-22 30-day Notice
S023 2016-11-22 30-day Notice
S022 2016-11-01 30-day Notice
S021 2016-06-30 30-day Notice
S020 2016-04-01 Panel Track
S019 2016-02-24 30-day Notice
S018 2015-08-31 Normal 180 Day Track
S017 2015-07-30 30-day Notice
S016 2015-07-29 30-day Notice
S015 2015-06-16 30-day Notice
S014 2015-05-05 Normal 180 Day Track
S013 2014-09-30 30-day Notice
S012 2014-07-31 30-day Notice
S011 2014-07-30 30-day Notice
S010 2014-07-29 30-day Notice
S009 2014-07-28 30-day Notice
S008 2014-06-17 135 Review Track For 30-day Notice
S007 2014-05-01 30-day Notice
S006 2013-09-13 30-day Notice
S005 2013-07-25 30-day Notice
S004 2012-11-02 30-day Notice
S003 2012-10-04 30-day Notice
S002 2012-05-01 135 Review Track For 30-day Notice
S001 2012-04-04 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00087541300912 P080020 012
04987541300911 P080020 012

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