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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 NameAPEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty (ptca) catheters
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP860019
Supplement NumberS208
Date Received04/24/2006
Decision Date11/07/2008
Product Code
LOX[ Registered Establishments with LOX ]
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 the apex monorail and over-the-wire percutaneous transluminal coronary angioplasty (ptca) catheters. The device, as modified, is indicated for: 1) (balloon models 1. 5 ¿ 5. 0 mm) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) (balloon models 2. 0 ¿ 5. 0 mm) for the post-delivery expansion of balloon expandable stents.
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