Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 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 NameEPIC SELF-EXPANDING NITINOL STENT SYSTEM
Classification Namestent, iliac
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP110035
Date Received09/13/2011
Decision Date04/13/2012
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 12M-0373
Notice Date 04/25/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00896337
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the epic vascular self-expanding stent system. This device is indicated for the improvement of luminal diameter in patients with de novo or restenotic symptomatic atherosclerotic lesions up to 120 mm in length in the common and/or external iliac arteries, with a reference vessel diameter between 5 and 11 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S010 S011 
-
-