PMA P040013S013

Device: GEM21S GROWTH FACTOR ENHANCED
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S013
Product code: NPZ
Decision date: 2008-08-29
Classification: Bone Grafting Material, Dental, With Biologic Component
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: APPROVAL FOR: 1) ADDITION OF A CLAIM THAT PDGF STIMULATES ANGIOGENESIS; 2) ADDITION OF A COMPARISON OF PIVOTAL CLINICAL TRIAL RESULTS OBTAINED WITH GEM 21S AND THE RESULTS PUBLISHED ON EMDOGAIN; AND 3) ADDITION OF 36 MONTH LONG TERM EFFICACY DATA TO THE ORIGINAL 6 MONTH STUDY.

Current openFDA PMA Record#

Device: GEM21S GROWTH FACTOR ENHANCED
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S013
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2008-08-29
Decision code: APPR
Date received: 2008-03-26
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR: 1) ADDITION OF A CLAIM THAT PDGF STIMULATES ANGIOGENESIS; 2) ADDITION OF A COMPARISON OF PIVOTAL CLINICAL TRIAL RESULTS OBTAINED WITH GEM 21S AND THE RESULTS PUBLISHED ON EMDOGAIN; AND 3) ADDITION OF 36 MONTH LONG TERM EFFICACY DATA TO THE ORIGINAL 6 MONTH STUDY.