Alinity m CMV

FDA Premarket Approval P210022 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

DeviceAlinity m CMV
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantAbbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS001 Date Received05/18/2022 Decision Date05/26/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-18
Decision Date2022-05-26
PMAP210022
SupplementS001
Product CodePAB 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Molecular, Inc.
1300 E. Touhy Avenue
des Plaines, IL 60018 PMA NumberP210022 Supplement NumberS001 Date Received05/18/2022 Decision Date05/26/2022 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  
extended Expiration Dating For A Critical Raw Material

Supplemental Filings

Supplement NumberDateSupplement Type
P210022Original Filing
S001 2022-05-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999049956 P210022 000
00884999049611 P210022 000
00884999049604 P210022 000
00884999049598 P210022 000

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