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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 NameFLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
Classification Namecatheter, angioplasty, peripheral, transluminal
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
Regulation Number870.1250
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP950020
Supplement NumberS010
Date Received09/13/2004
Decision Date07/18/2005
Product Code
LIT[ Registered Establishments with LIT ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design, manufacturing, and labeling changes in the cutting balloon, both over-the-wire (otw) and monorail (mr) configurations. The device, as modified, will be marketed under the trade name flextome cutting balloon 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.
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