• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 PMA to get an up-to-date view of this device.
 
Trade NameAFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS229
Date Received11/14/2012
Decision Date06/06/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Pproval for the following new ellipse/quadra assura/fortify assura implantable cardioverter defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d) models: 1) ellipse vr icd (cd1411-36, cd1411-36q, cd1411-36c, cd1411-36qc); 2) fortify assura vr icd (cd1357-40, cd1357-40q, cd1357-40c, cd1357-40qc); 3) ellipse dr icd (cd2411-36, cd2411-36q, cd2411-36c, cd2411-36qc); 4) fortify assura dr icd (cd2357-40, cd2357-40q, cd2357-40c, cd2357-40qc); 5) unify assura crt-d (cd3357-40, cd3357-40q, cd3357-40c, cd3357-40qc); and 6) quadra assura crt-d (cd3365-40, cd3365-40q, cd3365-40c, cd3365-40qc) as well as model 3330 version 17. 1 software for the model 3650 merlin patient care system programmer, model ex2000 version 6. 5 software for the models ex1150 and ex1100 merlin@home transmitters, and model mn5000 version 6. 5 software for the merlin. Net system.
Approval Order Approval Order
-
-