GEM 21S GROWTH-FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S011 · decided 2007-10-01
Approval details
- PMA number
- P040013
- Supplement
- S011
- Supplement type
- 135 Review Track For 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
- 2007-05-22
- Decision date
- 2007-10-01
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR A SCALE UP OF THE MANUFACTURING OF THE DRUG COMPONENT FOR THE GEM 21? COMBINATION PRODUCT.
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