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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 NameMAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
Classification Namestent, coronary
Generic Namestent, coronary
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980009
Supplement NumberS005
Date Received02/25/2000
Decision Date03/23/2000
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 the alternate sterilization facility located at gammaster ireland ltd. , westport, county mayo, ireland.
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