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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 NameFRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030035
Supplement NumberS088
Date Received08/31/2011
Decision Date09/28/2011
Product Code
NIK[ Registered Establishments with NIK ]
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 model 3300 version 12. 1. 10 software for the model 3650 merlin patient care system.
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