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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(R) PREMOUNTER STENT SYSTEMS
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS021
Date Received06/30/2000
Decision Date07/14/2000
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE CONTRACT STERILIZATION FACILITY LOCATED AT IBA (FORMERLY GRIFFITH MICRO SCIENCE, INC.), WILLOWBROOK, ILLINOIS.
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