GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)

Biologic Material, Dental

FDA Premarket Approval P040013 S020

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

Approval for final patient labeling.

DeviceGEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)
Classification NameBiologic Material, Dental
Generic NameBiologic Material, Dental
ApplicantLynch Biologics LLC
Date Received2015-01-21
Decision Date2015-03-09
PMAP040013
SupplementS020
Product CodeNQA
Advisory CommitteeDental
Supplement TypeSpecial (immediate Track)
Expedited ReviewNo
Combination Product No
Applicant Address Lynch Biologics LLC 5526 Joseph Street franklin, TN 37064

Supplemental Filings

Supplement NumberDateSupplement Type
P040013Original Filing
S025 2020-11-27 Real-time Process
S024 2020-04-17 Normal 180 Day Track No User Fee
S023 2020-03-24 Normal 180 Day Track No User Fee
S022 2019-03-21 Normal 180 Day Track No User Fee
S021 2015-06-22 Normal 180 Day Track No User Fee
S020 2015-01-21 Special (immediate Track)
S019 2014-05-05 135 Review Track For 30-day Notice
S018 2012-02-29 Special (immediate Track)
S017 2011-06-24 Normal 180 Day Track No User Fee
S016 2010-12-11 Normal 180 Day Track
S015 2009-08-14 Normal 180 Day Track No User Fee
S014 2009-07-06 Normal 180 Day Track No User Fee
S013 2008-03-26 Normal 180 Day Track
S012 2007-11-23 Normal 180 Day Track No User Fee
S011 2007-05-22 135 Review Track For 30-day Notice
S010
S009 2006-12-22 Special (immediate Track)
S008 2006-10-20 30-day Notice
S007
S006 2006-08-09 30-day Notice
S005 2006-07-31 Real-time Process
S004 2006-05-31 Normal 180 Day Track No User Fee
S003 2006-04-06 Normal 180 Day Track No User Fee
S002 2006-02-27 Real-time Process
S001

NIH GUDID Devices

Device IDPMASupp
00850001118002 P040013 000
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