• 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 NameCONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS141
Date Received01/16/2009
Decision Date03/11/2009
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following minor design changes: 1) two (2) ic design changes ¿ l310 and l354 2) two (2) alternate components ¿ diode change (currently: xd423 and proposed: xd445) ¿ insulated-gate bipolar transistor (igbt) change (currently: xd405 and proposed: xd447) 3) printed wire board (pwb) changes to accommodate the alternate (xd445 diode and xd447 igbt) components and manufacturability improvements. 4) four (4) ics (l303, l310, l354, and l409) to be transferred to an alternative ic fabrication vendor.
-
-