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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.
 
DeviceTAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP060008
Supplement NumberS053
Date Received05/19/2010
Decision Date12/01/2010
Withdrawal Date12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) A CHANGE OF THE SUPPLIER OF TOLUENE; AND 2) A CHANGE TO THE INCOMING TOLUENE SPECIFICATIONS. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 MM TO <= 4.00 MM IN DIAMETER.
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