GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S006 · decided 2006-09-08
Approval details
- PMA number
- P040013
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2006-08-09
- Decision date
- 2006-09-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- SCALING UP THE MANUFACTURING PROCESS TO MOVE FROM 2,000 UNIT BATCHES TO 20,000 UNIT BATCHES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.