PMA P040013S025

Device: GEM 21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S025
Product code: NPZ
Decision date: 2021-01-15
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Approval for extending the expiration of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix from 42 months to 48 months.

Current openFDA PMA Record#

Device: GEM 21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S025
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2021-01-15
Decision code: APPR
Date received: 2020-11-27
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for extending the expiration of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix from 42 months to 48 months.