• 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.
 
DeviceACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
Classification Namestent, carotid
Generic Namestent, carotid
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP040012
Supplement NumberS001
Date Received09/16/2004
Decision Date09/24/2004
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
-
-