• 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 | Inspections

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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
PMA NumberP990017
Supplement NumberS011
Date Received09/25/2000
Decision Date09/20/2001
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the five year follow-up protocol: a) changing the follow-up schedule; b) removing the ultrasound and ankle brachial indices (abi) assessments; c) replacing the annual physical exam for control patients with an annual telephone survey and computed tomography (ct) and physical exam at the five year mark; d) allowing an optional telephone survey for patients unable or unwilling to come to the investigational site; and e) excluding patients who have been converted from further study follow-up.