PMA P040013S015

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S015
Product code: NPZ
Decision date: 2009-11-13
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 AT LUITPOLD PHARMACEUTICALS, INC., IN SHIRLEY, NEW YORK, FOR THE PACKAGING (KITTING) OF THE GEM 21S.

Current openFDA PMA Record#

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S015
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2009-11-13
Decision code: APPR
Date received: 2009-08-14
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 AT LUITPOLD PHARMACEUTICALS, INC., IN SHIRLEY, NEW YORK, FOR THE PACKAGING (KITTING) OF THE GEM 21S.