PMA
P950042: PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
FDA PMA · SYSTEM, IMAGING, FLUORESCENCE · Novadaq Technologies, Inc.
Key facts
| PMA number | P950042 |
|---|---|
| Trade name | PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA |
| Generic name | SYSTEM, IMAGING, FLUORESCENCE |
| Applicant | Novadaq Technologies, Inc. |
| Owner/operator | STRYKER CORP. |
| Product code | MRK |
| Approval date | Sep 19, 1996 |
| Docket number | 97M-0122 |
| Notice date | Apr 1, 1997 |
| Establishment registration | 3012345110 |
| FEI number | 3002808513 |
At a glance
- 1–9 Supplements
- Feb 2, 2012 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- No Withdrawn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: