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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 Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS100
Date Received06/12/1995
Decision Date08/17/1995
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
NEW PTCA CATHETER BASED ON 4 MODIFICATIONS TO SCIMED EXPRESS PLUS II PTCA CATHETER:ADDTION OF LEAP BALLOON MATERIAL,THINNER BALLOON MARKER BAND,ORANGE MANIFOLD,II WILL BE DROPPED FROM NAME TRADE NAME:SCIMED LEAP EXPRESS PLUS PTCA CATHETER
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