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.
Addition of alternative testing location for a device component
Device | Alinity m HBV |
Generic Name | Hepatitis Viral B Dna Detection |
Applicant | Abbott Molecular, Inc. |
Date Received | 2021-02-05 |
Decision Date | 2021-03-08 |
PMA | P200013 |
Supplement | S004 |
Product Code | MKT |
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, Inc. 1300 E Touhy Ave des Plaines, IL 60018 |
Supplement Number | Date | Supplement Type |
---|---|---|
P200013 | Original Filing | |
S004 | 2021-02-05 | 30-day Notice |
S003 | 2021-02-05 | 30-day Notice |
S002 | ||
S001 | 2020-12-21 | 30-day Notice |