Approval for the addition of a manufacturing site at 10210 genetic center dr. , san diego, ca 92121 (gcd) for the manufacture of critical components, proteins and protein conjugates, of the rapid ffn cassette for thetliiq system
| Device | Rapid fFN for the TLiIQ System |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC. |
| Date Received | 2020-09-08 |
| Decision Date | 2020-10-02 |
| PMA | P920048 |
| Supplement | S018 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices