• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
Classification Namestent, iliac
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP090003
Date Received02/23/2009
Decision Date03/05/2010
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 10M-0135
Notice Date 03/24/2010
Advisory Committee Cardiovascular
Clinical Trials NCT00352222
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the express ld iliac premounted stent system. The device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S024 S025 S026 S027 S028 S029 
S030 S031 S033 S035 
-
-