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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
one scimed place
maple grove, MN 55311-1566
PMA NumberP860019
Supplement NumberS182
Date Received04/16/2002
Decision Date10/01/2002
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the quantum maverick monorail and otw ptca catheters and approval for an additional sterilization facility, cosmed of ri, coventry, rhode island. The quantum maverick monorail & otw ptca catheters are available in lengths of 8, 12, 15, 20 and 30 mm, with diameters ranging from 2. 00 to 4. 00 mm in 1/4mm increments and 4. 5 to 5. 0 mm in 1/2 mm increments (except for the 20 mm length). The devices, as modified, are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for the post delivery expansion of balloon expandable stents.