• 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 NameVITATRON LEGACY
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namesingle chamber, sensor driven, implantable pulse
Applicant MEDTRONIC INC.
PMA NumberP850051
Supplement NumberS077
Date Received07/06/2011
Decision Date08/04/2011
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change for the determination of worst case device representative for ethylene oxide (eo) residual testing for ethylene oxide sterilization.
-
-