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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMAGIC WALLSTENT EDNDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
two scimed place
maple grove, MN 
PMA NumberP980009
Supplement NumberS010
Date Received12/07/2001
Decision Date01/22/2002
Product Code
MAF[ Registered Establishments with MAF ]
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 TWO ALTERNATE MANUFACTURING FACILITIES FOR PACKAGING AND LABELING OPERATIONS LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
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