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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.
 
DeviceVERIFLEX FOR LIBERTE BARE METAL STENTS
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP040016
Supplement NumberS037
Date Received09/15/2009
Decision Date09/25/2009
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD AN ALTERNATE TRADE NAME FOR THE LIBERTÉ MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VERIFLEX BARE METAL CORONARY STENT AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.75 TO 5.00 MM.
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