|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||GORE VIABAHN ENDOPROSTHESIS|
|Classification Name||stent, superficial femoral artery|
|Applicant||W.L. GORE & ASSOCIATES,INC|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of fourier transform infrared spectroscopy, bacterial endotoxin testing, heavy metals as lead (hmal) and non-volatile residue (nvr) testing in the east coast testing center.