• 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.
 
DeviceBIOPOLYMERIC(TM) VASCULAR GRAFT
Classification Nametissue graft of 6mm and greater
Generic Nametissue graft of 6mm and greater
Applicant
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP800058
Supplement NumberS015
Date Received01/23/1993
Decision Date10/25/1994
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
-
-