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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 CORONARY DILATATION CATHETERS (INDICATION)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS170
Date Received11/25/1996
Decision Date05/13/1997
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: A) THE ADDITION OF THE INDICATION "BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION OFR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION"; AND (B) OTHER MODIFICATIONS OT THE CURRENT LABEL TO REFLECT THIS NEW INDICATION.
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