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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.
 
DeviceADANTE PTCA 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 NumberS154
Date Received03/15/1999
Decision Date04/05/1999
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the ADANTE(TM) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (20 mm length with balloon diameters of 1.5 mm, and 2.0 -4.0 mm in 1/4 mm increments, and 30 and 40 mm lengths with balloon diameters of 2.0 - 4.0 mm in 1/4 mm increments). The ADANTE(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocaridal perfusion. The ADANTE(TM) PTCA Catheter (balloon models 2.5 - 4.0 mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.
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