• 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.
 
DeviceEASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD
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 NumberS025
Date Received03/10/2004
Decision Date08/06/2004
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN FIXATION DESIGN, LEAD LENGTHS AND ENABLING BIPOLAR PACE/SENSE CAPABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK 3 AND IS INDICATED FOR CHRONIC, LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS, WHEN USED IN CONJUNCTION WITH A COMPATIBLE GUIDANT CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.
-
-