PMA supplement
P950042 S003: ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)
FDA PMA supplement · Panel Track · Novadaq Technologies, Inc.
Key facts
| Original PMA | P950042 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE) |
| Generic name | SYSTEM, IMAGING, FLUORESCENCE |
| Applicant | Novadaq Technologies, Inc. |
| Product code | MRK |
| Received date | Sep 30, 2004 |
| Decision date | Jun 30, 2005 |
| Docket number | 05M-0284 |
| Notice date | Jul 18, 2005 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: