GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S004 · decided 2006-07-17
Approval details
- PMA number
- P040013
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Trade name
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2006-05-31
- Decision date
- 2006-07-17
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR A NEW ELISA PDGF-BB IDENTITY TEST.
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