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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 SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS186
Date Received01/23/1998
Decision Date03/13/1998
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for ACS Swap-It(TM) Guide Wire Exchange Device which is an accessory to Guidant ACS RX (Rail) catheters. This device will be marketed under the trade name ACS Swap-It(TM) Guide Wire Exchange Device and is indicated for use within a guiding catheter to facilitate the exchange of a 0.014 inch guide wire while maintaining the position of an ACS RX(R) (Rail) catheter.
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