PMA P040013S006
- Device
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S006
- Product code
- NPZ
- Decision date
- 2006-09-08
- Classification
- Bone Grafting Material, Dental, With Biologic Component
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- SCALING UP THE MANUFACTURING PROCESS TO MOVE FROM 2,000 UNIT BATCHES TO 20,000 UNIT BATCHES.
Current openFDA PMA Record#
- Device
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S006
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2006-09-08
- Decision code
- OK30
- Date received
- 2006-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SCALING UP THE MANUFACTURING PROCESS TO MOVE FROM 2,000 UNIT BATCHES TO 20,000 UNIT BATCHES.