PMA P040013S024

Device: GEM21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S024
Product code: NPZ
Decision date: 2020-12-04
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Change in supplier for the formulation, filling, and testing (with the exception of the Bioassay) of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix to a manufacturing site located at Pyramid Laboratories, Inc., 3598 Cadillac Ave., Costa Mesa, CA 92626.

Current openFDA PMA Record#

Device: GEM21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S024
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2020-12-04
Decision code: APPR
Date received: 2020-04-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in supplier for the formulation, filling, and testing (with the exception of the Bioassay) of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix to a manufacturing site located at Pyramid Laboratories, Inc., 3598 Cadillac Ave., Costa Mesa, CA 92626.