PMA P040013S021
- Device
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S021
- Product code
- NQA
- Decision date
- 2015-08-21
- Generic name
- Biologic material, dental
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- GEM 21S GROWTH FACTOR ENHANCED MATRIX
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S021
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2015-08-21
- Decision code
- APPR
- Date received
- 2015-06-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.