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 | Rapid fFN for the TLiIQ System |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS022 Date Received03/31/2022 Decision Date04/13/2022 Product Code LKV Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-04-13 |
| PMA | P920048 |
| Supplement | S022 |
| Product Code | LKV |
| Advisory Committee | Toxicology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 1240 Elko Drive sunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS022 Date Received03/31/2022 Decision Date04/13/2022 Product Code LKV Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change In Incoming Release Criteria For The Nitrocellulose Component Of The Rapid FFN For The TLiIQ System |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920048 | Original Filing | |
| S023 | 2022-04-29 | 30-day Notice |
| S022 | 2022-03-31 | 30-day Notice |
| S021 | 2022-02-14 | 30-day Notice |
| S020 | 2021-04-09 | 30-day Notice |
| S019 | ||
| S018 | 2020-09-08 | 30-day Notice |
| S017 | 2020-07-10 | 30-day Notice |
| S016 | ||
| S015 | ||
| S014 | 2018-11-20 | 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | 2015-06-10 | Real-time Process |
| S010 | ||
| S009 | 2015-04-09 | Real-time Process |
| S008 | 2014-06-24 | 30-day Notice |
| S007 | ||
| S006 | 2008-09-29 | 30-day Notice |
| S005 | 2007-12-21 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2000-09-11 | Normal 180 Day Track |
| S002 | 1998-02-13 | Normal 180 Day Track |
| S001 | 1996-06-26 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 25420045500874 | P920048 | 001 |
| 15420045500877 | P920048 | 001 |
| 15420045500884 | P920048 | 001 |
| 15420045501164 | P920048 | 001 |
| 15420045501171 | P920048 | 001 |
| 25420045501154 | P920048 | 001 |
| 15420045500877 | P920048 | 006 |
| 15420045500884 | P920048 | 006 |
| 15420045501164 | P920048 | 008 |
| 15420045501171 | P920048 | 008 |
| 15420045505346 | P920048 | 009 |