GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S016 · decided 2011-05-27
Approval details
- PMA number
- P040013
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2010-12-11
- Decision date
- 2011-05-27
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR A CHANGE IN THE RH-PDGF-BB SYRINGE CAP MATERIAL, MADE BY BECTON DICKINSON, THE CAP SUPPLIER, FROM WEST 1883 TO HELOVET FM27, BASED ON A CHANGE IN BECTON DICKINSON RUBBER RAW MATERIALS SUPPLIERS.
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