GEM21S Growth Factor Enhanced Matrix
FDA premarket approval P040013/S027 · decided 2023-05-04
Approval details
- PMA number
- P040013
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM21S Growth Factor Enhanced Matrix
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2022-11-15
- Decision date
- 2023-05-04
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for the addition of a Flurotec coating to the piston stopper component in the syringe system of the final finished packaging.
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