PMA P040013S023

Device: GEM215 Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S023
Product code: NPZ
Decision date: 2020-06-17
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Approval for change of the supplier from STERIS (formerly Synergy Health) in Swindon, United Kingdom (STERIS Swindon), to the STERIS AST facility located at 9 Apollo Drive, Whippany, New Jersey, United States (STERIS Whippany), for sterilization of the ?-TCP cup component of the GEM21S device.

Current openFDA PMA Record#

Device: GEM215 Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S023
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2020-06-17
Decision code: APPR
Date received: 2020-03-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for change of the supplier from STERIS (formerly Synergy Health) in Swindon, United Kingdom (STERIS Swindon), to the STERIS AST facility located at 9 Apollo Drive, Whippany, New Jersey, United States (STERIS Whippany), for sterilization of the ?-TCP cup component of the GEM21S device.