GEM 21S GROWTH FACTOR ENHANCED MATRIX

Bone Grafting Material, Dental, With Biologic Component

FDA Premarket Approval P040013 S014

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 manufacturing site located in shirley, new york, for the manufacture of the recombinant human platelet-derived growth factor-bb syringe and a quality testing facility at another location in shirley, new york, for the testing for the raw material, finished product release, and stability with the exception of the bioassay for the drug component of the device.

DeviceGEM 21S GROWTH FACTOR ENHANCED MATRIX
Classification NameBone Grafting Material, Dental, With Biologic Component
Generic NameBone Grafting Material, Dental, With Biologic Component
ApplicantLynch Biologics LLC
Date Received2009-07-06
Decision Date2009-08-12
PMAP040013
SupplementS014
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
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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