PMA P040013S016

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S016
Product code: NPZ
Decision date: 2011-05-27
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR A CHANGE IN THE RH-PDGF-BB SYRINGE CAP MATERIAL, MADE BY BECTON DICKINSON, THE CAP SUPPLIER, FROM WEST 1883 TO HELOVET FM27, BASED ON A CHANGE IN BECTON DICKINSON RUBBER RAW MATERIALS SUPPLIERS.

Current openFDA PMA Record#

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S016
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2011-05-27
Decision code: APPR
Date received: 2010-12-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE RH-PDGF-BB SYRINGE CAP MATERIAL, MADE BY BECTON DICKINSON, THE CAP SUPPLIER, FROM WEST 1883 TO HELOVET FM27, BASED ON A CHANGE IN BECTON DICKINSON RUBBER RAW MATERIALS SUPPLIERS.