Aptima CMV Quant Assay

FDA Premarket Approval P210029 S001

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.

Pre-market Approval Supplement Details

DeviceAptima CMV Quant Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantHologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Supplement NumberS001 Date Received06/16/2022 Decision Date07/20/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-16
Decision Date2022-07-20
PMAP210029
SupplementS001
Product CodePAB 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressHologic, Inc.
10210 Genetic Center Drive
san Diego, CA 92121 PMA NumberP210029 Supplement NumberS001 Date Received06/16/2022 Decision Date07/20/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Add Additional Monitoring And Final Release Criteria

Supplemental Filings

Supplement NumberDateSupplement Type
P210029Original Filing
S001 2022-06-16 30-day Notice

NIH GUDID Devices

Device IDPMASupp
15420045514584 P210029 000
15420045514577 P210029 000
15420045514560 P210029 000
15420045514553 P210029 000

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