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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.
 
DeviceACS RX ESPRIT CORONARY DILATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS190
Date Received05/21/1998
Decision Date07/30/1998
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for additional balloon sizes for the ACS Avenger(TM) Coronary dilatation Catheter (quarter sizes within the range of 2.25-3.75 mm for the currently marketed 15mm and 20mm balloon lengths and half sizes in the rang eof 2.5-4.0mm for a 25mm balloon length.
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