PMA supplement
P100006 S005: AUGMENT INJECTABLE
FDA PMA supplement · Panel Track · Biomimetic Therapeutics, LLC
Key facts
| Original PMA | P100006 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | AUGMENT INJECTABLE |
| Generic name | Filler, bone void, synthetic peptide |
| Applicant | Biomimetic Therapeutics, LLC |
| Product code | NOX |
| Received date | Oct 31, 2016 |
| Decision date | Jun 12, 2018 |
| Docket number | 18M-2335 |
| Notice date | Jun 27, 2018 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: