PMA
P970036: NIC 1800 NEEDLE DISPOSAL SYSTEM
FDA PMA · Sharps needle destruction device · Nic, Ltd.
Key facts
| PMA number | P970036 |
|---|---|
| Trade name | NIC 1800 NEEDLE DISPOSAL SYSTEM |
| Generic name | Sharps needle destruction device |
| Applicant | Nic , Ltd. |
| Product code | MTV |
| Approval date | Sep 26, 1997 |
| Docket number | 98M-0039 |
| Notice date | Jan 30, 1998 |
At a glance
- 1–9 Supplements
- Jul 29, 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- No Withdrawn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: