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

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.
 
DeviceCOGNIS CRT-D
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS165
Date Received12/07/2007
Decision Date05/08/2008
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH. THE COGNIS CRT-D DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE-TO-SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR (LV) DYSFUNCTION (EJECTION FRACTION <=35%) AND QRS DURATION >=120 MS. THE TELIGEN DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
-
-