PMA
P120018: SHARPS TERMINATOR
FDA PMA · Sharps needle destruction device · Sharps Terminator, LLC
Key facts
| PMA number | P120018 |
|---|---|
| Trade name | SHARPS TERMINATOR |
| Generic name | Sharps needle destruction device |
| Applicant | Sharps Terminator, LLC |
| Product code | MTV |
| Approval date | Feb 17, 2016 |
| Docket number | 16M-0806 |
| Notice date | Mar 7, 2016 |
| FEI number | 3011328602 |
At a glance
- 1–9 Supplements
- Feb 16, 2018 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: