PMA supplement
P950042 S001: XILLIX-LIFE-LUNG
FDA PMA supplement · Normal 180 Day Track · Novadaq Technologies, Inc.
Key facts
| Original PMA | P950042 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | XILLIX-LIFE-LUNG |
| Generic name | SYSTEM, IMAGING, FLUORESCENCE |
| Applicant | Novadaq Technologies, Inc. |
| Product code | MRK |
| Received date | Apr 30, 1998 |
| Decision date | Jul 21, 1998 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: