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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 REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Name catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS149
Date Received08/21/1998
Decision Date05/28/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval requested for the scimed remedy coronary balloon dilatation infusion catheter. The device is indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion , and to infuse fluids such as heparinized saline, and thrombolytic agents such as urokinase, into the vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atm. The remedy catheter (2. 5 - 4. 0 mm balloon diameters)is also indicated for the post-delivery expansion of balloon expandable stents.
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