• 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.
 
DeviceVENTAK VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATION
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP960040
Supplement NumberS009
Date Received01/12/1999
Decision Date05/03/1999
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 the ventak(r) vr aicd(tm) system with model 2841 software, version 1. 4.
-
-