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 SECURA & MAXIMO II ICDS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS127
Date Received04/10/2008
Decision Date07/11/2008
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE INC. 3 RAMWARE, WHICH CONTAINS A DESIGN CHANGE TO ADDRESS AN ISSUE WITH THE L409 INTEGRATED CIRCUIT (IC) IN THE CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, SECURA DR D224DRG AND SECURA VR D224VRC, MAXIMO II DR D284DRG AND MAXIMO II VR D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
-
-