PMA P040013S031

Device: GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S031
Product code: NPZ
Decision date: 2024-03-22
Classification: Dental
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: removal of a pre-test qualification testing of FBS and BSA reagents used in culture preparation and of the Potency Bioassay and Specific Activity by Bioassay testing requirements from the stability testing protocol

Current openFDA PMA Record#

Device: GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S031
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2024-03-22
Decision code: OK30
Date received: 2024-02-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of a pre-test qualification testing of FBS and BSA reagents used in culture preparation and of the Potency Bioassay and Specific Activity by Bioassay testing requirements from the stability testing protocol