• 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 NameREVEAL LINQ SOFTWARE MODEL SWO26
Classification Namepacemaker/icd/crt non-implanted components
ApplicantMEDTRONIC, INC.
PMA NumberP890003
Supplement NumberS304
Date Received03/05/2014
Decision Date04/30/2014
Product Code
OSR[ Registered Establishments with OSR ]
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 model sw026 application software for the reveal linq implantable cardiac monitors used on the model 2090 and encore programmers.
-
-