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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Classification Namestent, renal
ApplicantBOSTON SCIENTIFIC
PMA NumberP060006
Supplement NumberS048
Date Received08/29/2013
Decision Date09/27/2013
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
P050019/s017 9/27/13 carotid wallstent® monorail® endoprosthesis pgsooos chilli ii® cooled ablation catheter, model8005 circucool pump, model2104 tubingkit, sterile cables boston scientific corporation maple grove mn 55311 use of new traceability/tracking software in the incoming receiving inspection area.
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