PMA P040013S028
- Device
- GEM21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S028
- Product code
- NPZ
- Decision date
- 2023-05-31
- Classification
- Dental
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- Change to a larger mixing vessel/clamp and an additional stoppering box, to the existing manufacturing line.
Current openFDA PMA Record#
- Device
- GEM21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S028
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2023-05-31
- Decision code
- OK30
- Date received
- 2023-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a larger mixing vessel/clamp and an additional stoppering box, to the existing manufacturing line.