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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NameCURRENT, CURRENT+, CURRENT ACCEL AND FORTIFY CRT-D'S
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL
PMA NumberP910023
Supplement NumberS232
Date Received04/30/2010
Decision Date06/22/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change from sj-4 to df-4 for st. Jude medical high voltage lead, implantable cardioverter-defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d) products.
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