GEM21S
FDA premarket approval P040013/S029 · decided 2024-01-04
Approval details
- PMA number
- P040013
- Supplement
- S029
- 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
- 2023-12-15
- Decision date
- 2024-01-04
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- qualification of two additional third-party sterilization locations and harmonization of sterilization dose for the stopper component of product syringe
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.