GEM21S
FDA premarket approval P040013/S028 · decided 2023-05-31
Approval details
- PMA number
- P040013
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM21S
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2023-05-01
- Decision date
- 2023-05-31
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Change to a larger mixing vessel/clamp and an additional stoppering box, to the existing manufacturing line.
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