GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S014 · decided 2009-08-12
Approval details
- PMA number
- P040013
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2009-07-06
- Decision date
- 2009-08-12
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN SHIRLEY, NEW YORK, FOR THE MANUFACTURE OF THE RECOMBINANT HUMAN PLATELET-DERIVED GROWTH FACTOR-BB SYRINGE AND A QUALITY TESTING FACILITY AT ANOTHER LOCATION IN SHIRLEY, NEW YORK, FOR THE TESTING FOR THE RAW MATERIAL, FINISHED PRODUCT RELEASE, AND STABILITY WITH THE EXCEPTION OF THE BIOASSAY FOR THE DRUG COMPONENT OF THE DEVICE.
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