• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameMARQUIS DR/VR 7274/7230 ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS150
Date Received08/20/2008
Decision Date10/24/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the rv lead integrity alert (rvlia) feature and model sw012, version 1. 1, rvlia software.
-
-