SUPARTZ FX and VISCO-3

FDA Premarket Approval P980044 S053

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

Automation of the existing bacterial endotoxin test process

DeviceSUPARTZ FX and VISCO-3
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSEIKAGAKU CORP.
Date Received2020-06-30
Decision Date2020-07-17
PMAP980044
SupplementS053
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
P980044Original Filing
S053 2020-06-30 30-day Notice
S052
S051 2018-12-20 30-day Notice
S050 2018-11-06 30-day Notice
S049 2018-10-16 30-day Notice
S048 2018-07-11 30-day Notice
S047 2018-05-18 Real-time Process
S046 2018-05-10 30-day Notice
S045 2018-04-25 30-day Notice
S044
S043 2018-02-13 30-day Notice
S042 2018-01-11 30-day Notice
S041 2017-11-14 30-day Notice
S040 2017-06-30 30-day Notice
S039 2017-06-29 135 Review Track For 30-day Notice
S038 2017-02-28 30-day Notice
S037 2017-02-24 30-day Notice
S036 2016-12-23 30-day Notice
S035 2016-08-19 30-day Notice
S034 2016-08-16 30-day Notice
S033
S032 2016-04-19 30-day Notice
S031 2016-02-23 30-day Notice
S030 2015-12-09 30-day Notice
S029 2015-11-10 30-day Notice
S028 2015-10-30 Normal 180 Day Track
S027 2015-07-08 Panel Track
S026 2015-06-17 30-day Notice
S025 2015-04-07 Normal 180 Day Track No User Fee
S024 2014-11-24 Normal 180 Day Track
S023 2014-11-21 30-day Notice
S022 2014-11-20 30-day Notice
S021 2014-11-19 30-day Notice
S020 2014-11-18 30-day Notice
S019 2014-08-29 30-day Notice
S018 2014-05-01 30-day Notice
S017 2013-12-18 30-day Notice
S016 2013-06-28 30-day Notice
S015 2013-06-12 30-day Notice
S014 2012-08-20 30-day Notice
S013 2012-04-04 30-day Notice
S012 2010-03-11 135 Review Track For 30-day Notice
S011
S010 2009-08-27 30-day Notice
S009 2009-02-26 Normal 180 Day Track No User Fee
S008 2008-07-30 30-day Notice
S007 2008-07-21 135 Review Track For 30-day Notice
S006 2007-01-30 Special (immediate Track)
S005 2006-08-01 135 Review Track For 30-day Notice
S004 2006-07-26 30-day Notice
S003 2004-09-14 Normal 180 Day Track
S002 2004-06-07 Normal 180 Day Track
S001 2004-04-29 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05060548950057 P980044 000
05060459970120 P980044 000
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
M717715644440 P980044 019
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04987541301314 P980044 027
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04987541301314 P980044 027
04987541301314 P980044 027
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04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027
04987541301314 P980044 027

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