Abbott RealTime CMV

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P160044 S002

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

Implement additional qc to device accessory kits.

• Device: Abbott RealTime CMV
• Classification Name: Cytomegalovirus (cmv) Dna Quantitative Assay
• Generic Name: Cytomegalovirus (cmv) Dna Quantitative Assay
• Applicant: ABBOTT MOLECULAR
• Date Received: 2019-04-10
• Decision Date: 2019-05-15
• PMA: P160044
• Supplement: S002
• Product Code: PAB
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: ABBOTT MOLECULAR 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement Number	Date	Supplement Type
P160044		Original Filing
S005	2022-12-20	30-day Notice
S004	2022-05-19	30-day Notice
S003	2021-02-05	30-day Notice
S002	2019-04-10	30-day Notice
S001	2017-06-27	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00884999047297	P160044	000
00884999045798	P160044	000
00884999045781	P160044	000
00884999045774	P160044	000