GEM 21S (GROWTH ENHANCED MATRIX)
FDA premarket approval P040013/S012 · decided 2008-09-03
Approval details
- PMA number
- P040013
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- GEM 21S (GROWTH ENHANCED MATRIX)
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2007-11-23
- Decision date
- 2008-09-03
- Days to decision
- 285 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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