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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.
 
DeviceABBOTT REALTIME HBV
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP080026
Supplement NumberS009
Date Received07/23/2013
Decision Date08/20/2013
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.
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