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.
| Device | Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | ABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS004 Date Received05/19/2022 Decision Date06/09/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-19 |
| Decision Date | 2022-06-09 |
| PMA | P160044 |
| Supplement | S004 |
| 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 PMA NumberP160044 Supplement NumberS004 Date Received05/19/2022 Decision Date06/09/2022 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 a Manufacturing Scale-up Of A Kit Component |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999047297 | P160044 | 000 |
| 00884999045798 | P160044 | 000 |
| 00884999045781 | P160044 | 000 |
| 00884999045774 | P160044 | 000 |