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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.
 
DeviceANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS009
Date Received05/19/2004
Decision Date06/22/2004
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PUMP SET (ALSO CALLED THE PUMP SET PLUS) WHICH INCLUDED: 1) MODIFICATION TO THE PUMP OUTLET AND INLET FITTINGS; 2) CHANGES TO THE DEPTH OF THE CHECK BALL SEAT AND ELIMINATION OF THE CHECK BALL SPRING; 3) CHANGES TO THE PRIME SENSOR CUP; 4) CHANGES TO THE PISTON HEAD; 5) COLOR CHANGES TO THE LUER; AND 6) CHANGES TO THE PARATUBING ASSEMBLY.
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