PMA P040013S014

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S014
Product code: NPZ
Decision date: 2009-08-12
Classification: Bone Grafting Material, Dental, With Biologic Component
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: 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.

Current openFDA PMA Record#

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S014
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2009-08-12
Decision code: APPR
Date received: 2009-07-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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.