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

Humanitarian Device Exemption (HDE)
  • 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 supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameContegra Pulmonary Valved Conduit
Classification Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Applicant
Medtronic, Inc.
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Supplement NumberS040
Date Received11/19/2020
Decision Date12/16/2020
Product Code
MWH[ Registered Establishments with MWH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A change in storage temperature requirements for the tissue fixation solution.
-
-