GEM21S GROWTH FACTOR ENHANCED
FDA premarket approval P040013/S013 · decided 2008-08-29
Approval details
- PMA number
- P040013
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM21S GROWTH FACTOR ENHANCED
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2008-03-26
- Decision date
- 2008-08-29
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- 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.
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