Warning letter
Entellus Medical: warning letter of Apr 6, 2017
FDA warning letter 511495 · Center for Devices and Radiological Health
Key facts
| Reference number | 511495 |
|---|---|
| Company | Entellus Medical |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Apr 6, 2017 |
| Posted date | Sep 5, 2017 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.46(a), 812.40, 812.42, 812, 812.35(a) |
| Inspection city | Portage |
| Inspection ZIP | 49002 |
| Inspection start date | Sep 8, 2016 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: