Gel-One

FDA Premarket Approval P080020 S051

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

DeviceGel-One
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS051 Date Received12/08/2022 Decision Date01/05/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-08
Decision Date2023-01-05
PMAP080020
SupplementS051
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSEIKAGAKU CORP.
6-1, Marunouchi 1-chome,
chiyoda-ku
tokyo 100-0-0005 PMA NumberP080020 Supplement NumberS051 Date Received12/08/2022 Decision Date01/05/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
sharing Of The Existing Gel-One Manufacturing Equipment In Preparation Building-3 In The SKK-Takahagi Plant To Manufacture Gel-One Samples Using H-HAD Manufactured AtSKK-Kurihama Plant

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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