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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 ON RANGER AND NIR ON RANGER WITH/SOX
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS004
Date Received02/09/1999
Decision Date03/10/1999
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in the specification of the balloon component for the NIR ON(TM) Ranger(TM) Premounted Stent System. This change applies only to the 9 mm length NIR ON(TM) Ranger(TM) Premounted Stent System with the 3.0mm, 3.5mm and 4.0mm balloon diameters.
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