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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 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 NameVENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS
Classification Nameprogrammer, pacemaker
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS041
Date Received01/16/2004
Decision Date03/09/2004
Product Code
KRG[ Registered Establishments with KRG ]
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 the firmware modifications of the following aicd systems: ventak prizm aicd system (models 1850, 1851, 1855, 1856) firmware version 1. 2 patch h, ventak prizm he aicd system (models 1852, 1853, 1857, 1858) firmware version 1. 2 patch h, ventak prizm 2 aicd system (models 1860, 1861) firmware version 1. 4 patch c, vitality ds/el aicd system (models t125, t127, t135) firmware version 1. 0 patch b, contak cd 2 (models h115, h119) firmware version 1. 2 patch h, and the application software model 2844 version 3. 7.
-
-