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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 TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS182
Date Received11/24/1997
Decision Date01/27/1998
Reclassified Date 10/08/2010
Product Code LOX 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for an E-beam sterilization process validation protocol and a manufacturing site located at Guidant Corporation, Advanced Cardiovascular Systems, 26531 Ynez Rd., Temecula, CA 92591-4628.
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