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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestent, iliac
Generic Nameiliac stent
PMA NumberP080007
Supplement NumberS007
Date Received09/26/2011
Decision Date11/16/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the pcrformaxx grip on the delivery system, the addition of a smaller packaging configuration, and minor labeling changes. The device, as modified, will be marketed under the trade name lifestar vascular stent system and is indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length with a reference vessel diameter of 5 to 9 mm.