GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S031 · decided 2024-03-22
Approval details
- PMA number
- P040013
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2024-02-28
- Decision date
- 2024-03-22
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- 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
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