GEM215 Growth Factor Enhanced Matrix

FDA Premarket Approval P040013 S023

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 change of the supplier from steris (formerly synergy health) in swindon, united kingdom (steris swindon), to the steris ast facility located at 9 apollo drive, whippany, new jersey, united states (steris whippany), for sterilization of the? -tcp cup component of the gem21s device.

DeviceGEM215 Growth Factor Enhanced Matrix
Generic NameBone Grafting Material, Dental, With Biologic Component
ApplicantLynch Biologics LLC
Date Received2020-03-24
Decision Date2020-06-17
PMAP040013
SupplementS023
Product CodeNPZ 
Advisory CommitteeDental
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Lynch Biologics LLC 5526 Joseph Street franklin, TN 37064

Supplemental Filings

Supplement NumberDateSupplement Type
P040013Original Filing
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.