GEM21S Growth Factor Enhanced Matrix
FDA premarket approval P040013/S022 · decided 2019-08-19
Approval details
- PMA number
- P040013
- Supplement
- S022
- 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
- 2019-03-21
- Decision date
- 2019-08-19
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval to change the supplier who fills the B-TCP cup component of the GEM21S device from A+ Secure Packaging to Alliance Contract Pharma.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.