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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 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.
 
DeviceANTHEM FAMILY OF DEVICES
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030035
Supplement NumberS102
Date Received08/16/2012
Decision Date09/12/2012
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE SUPPLIER FOR THE ELECTROMAGNETIC COIL RECEIVER USED IN THE VOICE COIL ASSEMBLY.
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