GEM 21S (GROWTH ENHANCED MATRIX)
FDA premarket approval P040013/S009 · decided 2007-08-10
Approval details
- PMA number
- P040013
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM 21S (GROWTH ENHANCED MATRIX)
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2006-12-22
- Decision date
- 2007-08-10
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR THE NEW REFERENCE STANDARD, WHICH IS USED IN THE FOLLOWING ANALYTICAL METHODS: RP-HPLC, SEC, SDS-PAGE, UV, BIOASSAY, ELISA, AND PHH.
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