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 IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Abbott Molecular Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP170005 Supplement NumberS004 Date Received03/10/2022 Decision Date04/11/2022 Product Code OWD Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-10 |
| Decision Date | 2022-04-11 |
| PMA | P170005 |
| Supplement | S004 |
| Product Code | OWD |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Molecular Inc. 1300 E. Touhy Avenue des Plaines, IL 60018 PMA NumberP170005 Supplement NumberS004 Date Received03/10/2022 Decision Date04/11/2022 Product Code OWD Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Addition Of Specifications To Quality Control Testing |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170005 | Original Filing | |
| S004 | 2022-03-10 | Special (immediate Track) |
| S003 | 2021-02-05 | 30-day Notice |
| S002 | 2020-12-21 | 30-day Notice |
| S001 | 2019-08-29 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999047051 | P170005 | 000 |
| 00884999047044 | P170005 | 000 |
| 00884999047037 | P170005 | 000 |