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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 Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, portosystemic, endoprosthesis
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP930031
Supplement NumberS011
Date Received12/20/2001
Decision Date01/10/2002
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility located at boston scientific ireland ltd. (bsil), galway, ireland and an alternate sterilization facility located at isotron, offaly, ireland.