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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 TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namescimed(r) ace(tm) 1cm tip ptca catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS113
Date Received05/02/1996
Decision Date04/09/1997
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 balloon dilatation and infusion catheter. The device will be marketed under the trade name scimed(r) transport(r) coronary balloon dilatation-infusion catheter and is indicatd for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis fo rthe purpose of improving myocardial perfusion. The transport(r) catheter is also intended to infusion fluids such as heparinized saline, and thrombolytic agents such as urokinase, intot eh vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atmospheres.
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