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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 NameSCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP860019
Supplement NumberS160
Date Received03/31/2000
Decision Date09/27/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the boston scientific scimed maverick(tm) monorail(tm) percutaneous transluminal coronary angioplasty (ptca) catheter (9, 12, 25, and 30 mm lengths with balloon diameters of 2. 0 - 4,0 mm in 1/4 mm increments, and 15 and 20 mm lengths with balloon diameters of 1. 5 mm and 2. 0 - 4. 0 mm in 1/4 mm increments. The maverick(tm) monorail 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) monorail ptca catheter (2. 25 - 4. 0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.
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