Gel-One

FDA Premarket Approval P080020 S036

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Installation of a new ultra-filtration water (uf water) treatment system within preparation building-3 for use in the manufacture of gel-one.

DeviceGel-One
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSEIKAGAKU CORP.
Date Received2020-02-25
Decision Date2020-03-16
PMAP080020
SupplementS036
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SEIKAGAKU CORP. 6-1, Marunouchi 1-chome, chiyoda-ku tokyo 100-0-0005

Supplemental Filings

Supplement NumberDateSupplement Type
P080020Original Filing
S037 0000-00-00
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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