• 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.
 
Trade NameARTEGRAFT COLLAGEN VASCULAR GRAFT
Classification Nametissue graft of 6mm and greater
Generic Namevascular graft prosthesis of animal origin
ApplicantARTEGRAFT, INC.
PMA NumberN16837
Supplement NumberS020
Date Received04/01/2015
Decision Date04/29/2015
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the instructions for use brochure including: 1) change the size labeling convention from outer to inner diameter; and 2) the addition of an information statement not made with natural rubber latex.
-
-