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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.
 
DevicePOSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS020
Date Received09/29/2006
Decision Date03/28/2007
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE SPIROFLEX VG CATHETER THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM: SPIROFLEX VG RAPID EXCHANGE RHEOLYTIC THROMBECTOMY CATHETER AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SAPHENOUS VEIN GRAFT LESIONS IN VESSELS >= 3 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
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