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

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

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.
 
DeviceNEW BRANSON ULTRASONIC WELDER GENII
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS147
Date Received04/12/2016
Decision Date10/28/2016
Product Code DYE 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new Branson Ultrasonic Welding Gen II machine at Edwards Irvine, California facility.
  We welcome your comments and feedback about Devices@FDA.
-
-