Stryker Wingspan Stent System: Safety Communication - Narrowed Indications for Use
MedSun: Newsletter #76, September 2012

FDA Medical Device Safety

The FDA is informing health care providers and patients that the indications for use and labeling for the Wingspan stent have changed to limit the use of Wingspan to a narrow, select group of patients and conditions. Generally, a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB).

Additional Information:

FDA Medical Device Safety. Stryker Wingspan Stent System: Safety Communication - Narrowed Indications for Use. August 8, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314836.htm


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