• 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.
 
DeviceCONTAK RENEWAL 3 AVT CRT-D SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS037
Date Received11/10/2004
Decision Date03/13/2008
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 08M-0243
Notice Date 04/24/2008
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE CONTAK RENEWAL 3 AVT AND CONTAK RENEWAL 3 AVT HE SYSTEMS. THE SYSTEMS ARE INDICATED FOR THE FOLLOWING: CONTAK RENEWAL 3 AVT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS. CONTAK RENEWAL 3 AVT PROVIDES ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT FOR PATIENTS WITH A HISTORY OF OR WHO ARE AT RISK OF DEVELOPING ATRIAL ARRHYTHMIAS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
-
-