PMA P040013
- Device
- GEM 21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S025
- Product code
- NPZ
- Decision date
- 2024-11-22
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- to change the intake validation for a new raw material supplier of the rh-PDGF-BB syringe component of GEM21S
Current openFDA PMA Record#
- Device
- GEM 21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S032
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2024-11-22
- Decision code
- OK30
- Date received
- 2024-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change the intake validation for a new raw material supplier of the rh-PDGF-BB syringe component of GEM21S