• 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 NameILESTO,IFORIA,LUMAX
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS065
Date Received04/30/2013
Decision Date05/29/2013
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
-
-