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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/OTW SOLARIS CORONARY DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS200
Date Received01/20/2000
Decision Date02/16/2000
Reclassified Date10/08/2010
Product Codes DYG LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
A revision to the Instructions for Use booklet for ACS RX SOLARIS and ACS OTW SOLARIS Coronary Dilatation Catheters to include the addition fo the ACS Multi-Link Tristar Stent to the sections pertaining to post-implant stent dilatation.
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