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) | 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.
 
DeviceRX ACCULINK CARTOID STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP040012
Supplement NumberS044
Date Received03/20/2012
Decision Date08/24/2012
Product Code NIM 
Advisory Committee Cardiovascular
Clinical TrialsNCT00004732
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO UPDATE THE LABELING WITH LONG TERM CREST STUDY RESULTS.
-
-