PMA P040013S009

Device: GEM 21S (GROWTH ENHANCED MATRIX)
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S009
Product code: NPZ
Decision date: 2007-08-10
Classification: Bone Grafting Material, Dental, With Biologic Component
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR THE NEW REFERENCE STANDARD, WHICH IS USED IN THE FOLLOWING ANALYTICAL METHODS: RP-HPLC, SEC, SDS-PAGE, UV, BIOASSAY, ELISA, AND PHH.

Current openFDA PMA Record#

Device: GEM 21S (GROWTH ENHANCED MATRIX)
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S009
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2007-08-10
Decision code: APPR
Date received: 2006-12-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE NEW REFERENCE STANDARD, WHICH IS USED IN THE FOLLOWING ANALYTICAL METHODS: RP-HPLC, SEC, SDS-PAGE, UV, BIOASSAY, ELISA, AND PHH.