PMA
P960018: THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2
FDA PMA · Sharps needle destruction device · Healthcare Products Plus, Inc.
Key facts
| PMA number | P960018 |
|---|---|
| Trade name | THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2 |
| Generic name | Sharps needle destruction device |
| Applicant | Healthcare Products Plus, Inc. |
| Product code | MTV |
| Approval date | Jul 16, 1998 |
| Docket number | 98M-0619 |
| Notice date | Aug 17, 1998 |
| FEI number | 3002668534 |
At a glance
- 1–9 Supplements
- Nov 17, 1998 Latest supplement decision
- No Withdrawn
- No 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: