GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)
FDA premarket approval P040013/S018 · decided 2014-07-11
Approval details
- PMA number
- P040013
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2012-02-29
- Decision date
- 2014-07-11
- Days to decision
- 863 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR THE REVISION OF THE GEM 21S PACKAGE INSERT.
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