• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP060008
Supplement NumberS008
Date Received11/28/2008
Decision Date05/21/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 09M-0255
Notice Date 06/03/2009
Advisory Committee Cardiovascular
Clinical Trials NCT00371748
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 2. 25 mm taxusliberte paclitaxel-eluting coronary stent system. This device size will be marketed under thetrade name taxus liberte atom paclitaxel-eluting coronary stent system (monorail and over-the-wire delivery systems), and is indicated for improving luminal diameter for thetreatment of de novo lesions in native coronary arteries > =2. 25 mm to <= 4. 00 mm in diameter inlesions <= 28 mm in length.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress