• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP060008
Supplement NumberS011
Date Received02/02/2009
Decision Date07/13/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 09M-0369
Notice Date 08/04/2009
Advisory Committee Cardiovascular
Clinical Trials NCT00371478
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 38 MM LENGTH TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME TAXUS LIBERTÉ LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.75 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
-
-