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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.
 
DeviceRealTime CMV Assay
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantAbbott Molecular
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP160044
Supplement NumberS005
Date Received12/20/2022
Decision Date01/13/2023
Reclassified Date10/23/2024
Product Code PAB 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Supplier site relocation with process changes for a critical component.
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