PMA P040013

Device: GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S025
Product code: NPZ
Decision date: 2026-08-03
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: implementation of a Restricted Access Barrier System (RABS) to the syringe filler unit for the filling of the rhPDGF-BB syringe component of GEM21S

Current openFDA PMA Record#

Device: GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S033
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2026-08-03
Decision code: APPR
Date received: 2026-01-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a Restricted Access Barrier System (RABS) to the syringe filler unit for the filling of the rhPDGF-BB syringe component of GEM21S