GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S021 · decided 2015-08-21
Approval details
- PMA number
- P040013
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Generic name
- Biologic material, dental
- Applicant
- Lynch Biologics, LLC
- Date received
- 2015-06-22
- Decision date
- 2015-08-21
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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