PMA
P100006: AUGMENT BONE GRAFT
FDA PMA · Filler, bone void, synthetic peptide · Biomimetic Therapeutics, LLC
Key facts
| PMA number | P100006 |
|---|---|
| Trade name | AUGMENT BONE GRAFT |
| Generic name | Filler, bone void, synthetic peptide |
| Applicant | Biomimetic Therapeutics, LLC |
| Owner/operator | STRYKER CORP. |
| Product code | NOX |
| Approval date | Sep 1, 2015 |
| Docket number | 15M-3257 |
| Notice date | Oct 13, 2015 |
| Establishment registration | 3003897776 |
| FEI number | 3003897776 |
At a glance
- 10–99 Supplements
- Jun 13, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: