GEM 21S GROWTH-FACTOR ENHANCED MATRIX

Bone Grafting Material, Dental, With Biologic Component

FDA Premarket Approval P040013 S011

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 a scale up of the manufacturing of the drug component for the gem 21? Combination product.

• Device: GEM 21S GROWTH-FACTOR ENHANCED MATRIX
• Classification Name: Bone Grafting Material, Dental, With Biologic Component
• Generic Name: Bone Grafting Material, Dental, With Biologic Component
• Applicant: Lynch Biologics LLC
• Date Received: 2007-05-22
• Decision Date: 2007-10-01
• PMA: P040013
• Supplement: S011
• Product Code: NPZ
• Advisory Committee: Dental
• Supplement Type: 135 Review Track For 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Lynch Biologics LLC 5526 Joseph Street franklin, TN 37064

Supplemental Filings

Supplement Number	Date	Supplement Type
P040013		Original 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 ID	PMA	Supp
00850001118002	P040013	000