AUGMENT Injectable
FDA premarket approval P100006/S008 · decided 2019-06-11
Approval details
- PMA number
- P100006
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AUGMENT Injectable
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Biomimetic Therapeutics, LLC
- Date received
- 2018-10-23
- Decision date
- 2019-06-11
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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