PMA P040013S030
- Device
- GEM21S® Growth Factor Enhanced Matrix
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S030
- Product code
- NPZ
- Decision date
- 2024-02-14
- Classification
- Dental
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- extension of the expiry date for the Beta-TCP cup component of GEM21S to 48 months
Current openFDA PMA Record#
- Device
- GEM21S® Growth Factor Enhanced Matrix
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S030
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2024-02-14
- Decision code
- OK30
- Date received
- 2024-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- extension of the expiry date for the Beta-TCP cup component of GEM21S to 48 months