GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)
FDA premarket approval P040013/S020 · decided 2015-03-09
Approval details
- PMA number
- P040013
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Trade name
- GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)
- Generic name
- Biologic material, dental
- Applicant
- Lynch Biologics, LLC
- Date received
- 2015-01-21
- Decision date
- 2015-03-09
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR FINAL PATIENT LABELING.
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