GEM 21S Growth Factor Enhanced Matrix
FDA premarket approval P040013/S025 · decided 2021-01-15
Approval details
- PMA number
- P040013
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM 21S Growth Factor Enhanced Matrix
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2020-11-27
- Decision date
- 2021-01-15
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for extending the expiration of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix from 42 months to 48 months.
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