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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.
 
DeviceLEAP EXPRESS PLUSS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS101
Date Received07/05/1995
Decision Date08/22/1995
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO CHANGE THE SCIMED EXPRESS PLUS II PTCA CATHETER'S NAME TO POC EXPRESS PLUS AND TO MODIFY THE LABELING TO BE CONSISTENT WITH THE OTHER PTCA CATHETERS UNDER P860019
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