GEM21S Growth Factor Enhanced Matrix
FDA premarket approval P040013/S024 · decided 2020-12-04
Approval details
- PMA number
- P040013
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM21S Growth Factor Enhanced Matrix
- Generic name
- Bone grafting material, dental, with biologic component
- Applicant
- Lynch Biologics, LLC
- Date received
- 2020-04-17
- Decision date
- 2020-12-04
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Change in supplier for the formulation, filling, and testing (with the exception of the Bioassay) of the rhPDGF-BB syringe component of GEM21S Growth Factor Enhanced Matrix to a manufacturing site located at Pyramid Laboratories, Inc., 3598 Cadillac Ave., Costa Mesa, CA 92626.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.