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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 NumberS032
Date Received05/07/2001
Decision Date05/29/2001
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A REDUCTION OF THE INTERNAL DIAMETER OF THE PROXIMAL SHAFT FROM 0.0205" TO 0.0190" ON THE FOLLOWING PREMOUNTED STENT SYSTEMS: NOROYAL(TM) ADVANCE, NIROYAL(TM) ELITE AND NIR(TM) ELITE.
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