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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 PRIMO PREMOUNTED STENT SYSTEM
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS008
Date Received05/10/1999
Decision Date06/11/1999
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(TM) Primo(TM) Premounted Stent System. This change applies only to the 9 mm length NIR(TM) Primo(TM) Premounted Stent System with the 3.0 mm, 3.5 mm, and 4.0 mm balloon diameters.
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