PMA P040013S011
- Device
- GEM 21S GROWTH-FACTOR ENHANCED MATRIX
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S011
- Product code
- NPZ
- Decision date
- 2007-10-01
- Classification
- Bone Grafting Material, Dental, With Biologic Component
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- APPROVAL FOR A SCALE UP OF THE MANUFACTURING OF THE DRUG COMPONENT FOR THE GEM 21? COMBINATION PRODUCT.
Current openFDA PMA Record#
- Device
- GEM 21S GROWTH-FACTOR ENHANCED MATRIX
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S011
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2007-10-01
- Decision code
- APPR
- Date received
- 2007-05-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A SCALE UP OF THE MANUFACTURING OF THE DRUG COMPONENT FOR THE GEM 21? COMBINATION PRODUCT.