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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS024
Date Received06/06/2005
Decision Date07/18/2005
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CARELINK MONITOR MODEL 2490G FOR USE WITH ADDITIONAL PULSE GENERATOR MODELS, SPECIFICALLY THE INSYNC SENTRY MODEL 7299, INSYNC MAXIMO MODEL 7304, AND THE V-V TIMING FEATURE FOR BOTH THE INSYNC SENTRY MODEL 7297 AND THE INSYNC MAXIMO MODEL 7303. THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
-
-