GEM 21S GROWTH FACTOR ENHANCED MATRIX
FDA premarket approval P040013/S015 · decided 2009-11-13
Approval details
- PMA number
- P040013
- Supplement
- S015
- 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
- 2009-08-14
- Decision date
- 2009-11-13
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NPZ
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT LUITPOLD PHARMACEUTICALS, INC., IN SHIRLEY, NEW YORK, FOR THE PACKAGING (KITTING) OF THE GEM 21S.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.