PMA
P980015: SHARPX
FDA PMA · Sharps needle destruction device · Innovative Medical Systems, Inc.
Key facts
| PMA number | P980015 |
|---|---|
| Trade name | SHARPX |
| Generic name | Sharps needle destruction device |
| Applicant | Innovative Medical Systems, Inc. |
| Product code | MTV |
| Approval date | Aug 6, 1998 |
| Docket number | 98M-0679 |
| Notice date | Sep 17, 1998 |
At a glance
- 1–9 Supplements
- Jun 12, 2002 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- No Withdrawn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: