PMA P100006S001
- Device
- AUGMENT BONE GRAFT
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S001
- Product code
- NOX
- Decision date
- 2015-10-05
- Classification
- Filler, Bone Void, Synthetic Peptide
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- APPROVAL FOR PROPOSED EDITS TO THE PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- AUGMENT BONE GRAFT
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S001
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2015-10-05
- Decision code
- APPR
- Date received
- 2015-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR PROPOSED EDITS TO THE PACKAGE INSERT.