• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • 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 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.
 
DeviceSYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake rd.
tucson, AZ 85713
PMA NumberP030011
Supplement NumberS023
Date Received12/18/2013
Decision Date03/18/2014
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MINOR CHANGE TO THE COMPANION 2 DRIVER SYSTEMEXTERNAL BATTERY.
-
-