GEM 21S GROWTH FACTOR ENHANCE MATRIX
FDA premarket approval P040013/S019 · decided 2014-10-21
Approval details
- PMA number
- P040013
- Supplement
- S019
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM 21S GROWTH FACTOR ENHANCE MATRIX
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2014-05-05
- Decision date
- 2014-10-21
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR A NEW FILTRATION STEP AND RENOVATIONS AT THE SHIRLEY, NEW YORK MANUFACTURING FACILITY.
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