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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 GRUNTZIG DILICA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI PROCROSS ELITE OVER THE WIRE W/PRO/PEL COATING
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nametransluminal coronary angioplasty catheters, per
Regulation Number870.5100
ApplicantC.R. BARD, INC.
PMA NumberP790017
Supplement NumberS058
Date Received10/03/1995
Decision Date05/13/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the usci procross elite over the wire balloon dilatation catheter wtih pro/pel coating and anti back bleed device.
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