GEM215 Growth Factor Enhanced Matrix
FDA premarket approval P040013/S023 · decided 2020-06-17
Approval details
- PMA number
- P040013
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM215 Growth Factor Enhanced Matrix
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2020-03-24
- Decision date
- 2020-06-17
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for change of the supplier from STERIS (formerly Synergy Health) in Swindon, United Kingdom (STERIS Swindon), to the STERIS AST facility located at 9 Apollo Drive, Whippany, New Jersey, United States (STERIS Whippany), for sterilization of the ?-TCP cup component of the GEM21S device.
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