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 NameAMPLATZER PFO OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
AGA MEDICAL CORP.
682 mendelssohn ave.
golden valley, MN 55427
HDE NumberH000007
Supplement NumberS009
Date Received10/26/2005
Decision Date05/16/2006
Product Code
MLV[ Registered Establishments with MLV ]
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 for the use of an alternate pigment to be used during manufacture of the pitfe tubing components of the amplatzerv delivery and exchange systemsheaths, dilators and loaders.
-
-