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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 NameUSCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nametransluminal coronary angioplasty catheters, per
Regulation Number870.5100
ApplicantC.R. BARD, INC.
PMA NumberP790017
Supplement NumberS062
Date Received05/30/1997
Decision Date12/01/1997
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 a new ptca catheter line. The device, as modified, will be marketed under the trade name usci* apollo* rely over-the-wire balloon dilatation catheter with hydro/pel* coating and miniquet* device and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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