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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.
 
DeviceWOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP950020
Supplement NumberS072
Date Received01/29/2016
Decision Date08/18/2016
Product Code NWX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updates to the atherotomes, adhesive, balloon catheter platform, device packaging and the sterilization process. The device, as modified, will be marketed under the trade name WOLVERINE Coronary Cutting Balloon (Monorail & Over-The-Wire) and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: Discrete (<15 mm in length), or tubular (10 mm to 20 mm in length); Reference Vessel Diameter (RVD) of 2.00 mm to 4.00 mm; Readily accessible to the device; Light to moderate tortuosity of proximal vessel segment; Non-angulated lesion segment (<45 Degrees); Smooth angiographic contour; Absence of angiographically visible thrombus and/or calcification.
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