PMA P100006S002
- Device
- AUGMENT BONE GRAFT
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S002
- Product code
- NOX
- Decision date
- 2016-03-16
- Classification
- Filler, Bone Void, Synthetic Peptide
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- Approval of the protocol for the ODE Lead PMA Post-Approval Study.
Current openFDA PMA Record#
- Device
- AUGMENT BONE GRAFT
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S002
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2016-03-16
- Decision code
- APPR
- Date received
- 2015-09-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the ODE Lead PMA Post-Approval Study.