Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
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 NameMEDTRONIC VISION SOFTWARE SERIES 4.0
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameautomatic implantable cardioverter/defibrillator
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS043
Date Received02/22/2001
Decision Date03/15/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the programming software to be used with the medtronic gem (model 9962 software) icd system. The device, as modified, will be marketed under the trade name of medtronic vision software series 4. 0.
-
-