PMA P040013S005

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S005
Product code: NPZ
Decision date: 2006-08-21
Generic name: Bone grafting material, dental, with biologic component
Approval order 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.

Current openFDA PMA Record#

Device: GEM 21S GROWTH FACTOR ENHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S005
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2006-08-21
Decision code: APPR
Date received: 2006-07-31
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.