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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.
 
DeviceNIR PREMOUNTED STENT SYSTEMS
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS025
Date Received09/18/2000
Decision Date10/12/2000
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
THE 30-DAY NOTICE PROPOSED A CHANGE IN AN IN-PROCESS INSPECTION STEP TO REMOVE THE STENT IMPRINT AS A REJECTION CRITERION FOR THE ELASTOMERIC RETAINING SLEEVE COMPONENT ACCEPTANCE
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