PMA P040013S012
- Device
- GEM 21S (GROWTH ENHANCED MATRIX)
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S012
- Product code
- NPZ
- Decision date
- 2008-09-03
- Classification
- Bone Grafting Material, Dental, With Biologic Component
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- GEM 21S (GROWTH ENHANCED MATRIX)
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S012
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2008-09-03
- Decision code
- APPR
- Date received
- 2007-11-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY.