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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSCIMED REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS149
Date Received08/21/1998
Decision Date05/28/1999
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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