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 (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
Generic Namepulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
Regulation Number870.1250
Applicant
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Supplement NumberS014
Date Received02/25/2013
Decision Date09/24/2013
Product Code
OMZ[ Registered Establishments with OMZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of post-approval study protocol.
-
-