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 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.
 
Trade NameNEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
Classification Namestent, carotid
Generic Nameintravascular stent with delivery system
ApplicantMAQUET CARDIOVASCULAR LLC
PMA NumberP050025
Supplement NumberS007
Date Received12/07/2007
Decision Date12/20/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling clarification for ?arrythmia?, the addition of ?stent fracture? to the list of potential adverse events, and clarifications to the labeling to clarify complete removal of the delivery system tracking tip from guide heath or guide catheter when removing the device under fluoroscopy (items 11, 12, and 17 or table 1).
-
-