PMA P040013S018
- Device
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S018
- Product code
- NPZ
- Decision date
- 2014-07-11
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- APPROVAL FOR THE REVISION OF THE GEM 21S PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S018
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2014-07-11
- Decision code
- APPR
- Date received
- 2012-02-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REVISION OF THE GEM 21S PACKAGE INSERT.