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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.
 
DeviceAptima CMV Quant Assay
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantHologic, Inc.
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP210029
Supplement NumberS002
Date Received09/25/2024
Decision Date10/23/2024
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  
a modification of a test method
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