• 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 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.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS014
Date Received06/20/2003
Decision Date10/21/2003
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an expanded indication for your marketed cardiac resynchronization therapy (crt) devices. The devices are indicated for: patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <= 35%) and qrs duration >=120 ms and remain symptomatic despite stable, optimal heart failure drug therapy. Patient populations at high risk of sudden cardiac death due to ventricular arrhythmias include, but are not limited to those with: 1) survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia. 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note: the clinical outcome of hemodynamically stable sustained vt patients is not fully known. Safety and effectiveness studies have not been conducted. 3) prior myocardial infarction, left ventricular ejection fraction of <=35%, and a documented episode of nonsustained vt, with an inducible ventricular tachyarrhythmia. Patients suppressible with iv procainamide or an equivalent antiarrhythmic drug have not been studied. 4) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction <=30%.