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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.
 
DeviceROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
Two Scimed Pl.
Maple Grove, MN 55311
PMA NumberP900056
Supplement NumberS099
Date Received03/08/2010
Decision Date08/13/2010
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) CHANGE FROM IN-HOUSE MOULDING OF FOUR COMPONENTS TO AN OUTSOURCED MOULDING VENDOR; 2) A CHANGE IN THE MOULDING GATE DESIGN AND LOCATION; 3) CHANGE IN MOULDING MACHINE; AND 4) CHANGE IN THE INSPECTION PROCESS FOR THE COMPONENTS.
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