PMA P040013S029
- Device
- GEM21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S029
- Product code
- NPZ
- Decision date
- 2024-01-04
- Classification
- Dental
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- qualification of two additional third-party sterilization locations and harmonization of sterilization dose for the stopper component of product syringe
Current openFDA PMA Record#
- Device
- GEM21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S029
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2024-01-04
- Decision code
- OK30
- Date received
- 2023-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of two additional third-party sterilization locations and harmonization of sterilization dose for the stopper component of product syringe