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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 DELIVERY SYSTEM
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS013
Date Received10/06/1999
Decision Date11/04/1999
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 requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the NIR(TM) PRIMO(TM) Premounted Stent Delivery System.
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