- Device
- GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S008
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2006-11-17
- Decision code
- OK30
- Date received
- 2006-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AAI PHARMA-WILMINGTON FACILITY AS A QUALIFIED FACILITY TO CONDUCT A BIOASSAY ON THE DRUG COMPONENT OF THE DEVICE.