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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.
 
Trade NameRX HERCULINK ELITE RENAL STENT SYSTEM
Classification Namestent, renal
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP110001
Supplement NumberS009
Date Received08/02/2012
Decision Date10/09/2012
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at abbott vascular cardiac therapies in clonmel, ireland.
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