PMA P040013S002

Device: GEM 21S GROWTH FACTOR ENCHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S002
Product code: NPZ
Decision date: 2006-03-27
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR EXPIRY DATE OF 24 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 ENCHANCED MATRIX
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S002
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2006-03-27
Decision code: APPR
Date received: 2006-02-27
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR EXPIRY DATE OF 24 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.