GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S005 · decided 2006-08-21
Approval details
- PMA number
- P040013
- Supplement
- S005
- Supplement type
- Real-Time Process
- 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
- 2006-07-31
- Decision date
- 2006-08-21
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR THE BMPI STERILITY TEST METHOD TO EXTEND THE EXPIRY DATE TO 36 MONTHS AND IS INDICATED TO TREAT THE FOLLOWING PERIODONTALLY RELATED DEFECTS: 1) INTRABONY PERIODONTAL DEFECTS; 2) FURCATION PERIODONTAL DEFECTS; AND 3) GINGIVAL RECESSION ASSOCIATED WITH PERIODONTAL DEFECTS.
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