PMA P100006
- Device
- Augment® Bone Graft
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S013
- Product code
- NOX
- Decision date
- 2022-06-13
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- Approval for a modified package insert incorporating updated clinical data based on completion of the postapproval clinical study.
Current openFDA PMA Record#
- Device
- Augment® Bone Graft
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S013
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2022-06-13
- Decision code
- APPR
- Date received
- 2021-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a modified package insert incorporating updated clinical data based on completion of the postapproval clinical study.