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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 NumberS162
Date Received04/12/2000
Decision Date10/05/2000
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 boston scientific scimed maverick(tm) over-the-wire (otw) percutaneous transluminal coronary angioplasty (ptca) catheter (9, 12, 15, 20, 25 and 30 mm lengths with balloon diameters of 2. 0 - 4. 0 mm in 1/4 mm increments, and 9, 15 and 20 mm lengths with balloon diameters of 1. 5 mm). The maverick(tm) otw ptca catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The maverick(tm) otw ptca catheter (2. 25 - 4. 0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.