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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.
 
DeviceCORONARY DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS208
Date Received05/10/2001
Decision Date06/05/2001
Reclassified Date 10/08/2010
Product Codes DYG LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATIONS OF WHITE FOIL MARKERS IN THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), AND ACS ESPRIT PTCA CATHETERS.
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