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 NameMELODY TRANSCATHETER PULMONARY VALVE
Classification Namepulmonary valve prosthesis percutaneously delivered
Generic Namepulmonary valve prosthesis percutaneously delivered
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS018
Date Received04/15/2013
Decision Date07/31/2013
Product Code
NPV[ Registered Establishments with NPV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to use two new autoclaves.
-
-