Approval for a change to the bioburden determination method.
| Device | HEMOBLAST Bellows |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | Biom'Up France SAS |
| Date Received | 2020-04-29 |
| Decision Date | 2020-09-11 |
| PMA | P170012 |
| Supplement | S023 |
| Product Code | PMX |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biom'Up France SAS 8 Allee Irene Joliot Curie saint-priest 69800 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170012 | | Original Filing |
| S028 |
2021-11-23 |
135 Review Track For 30-day Notice |
| S027 |
2021-09-13 |
30-day Notice |
| S026 | | |
| S025 |
2021-01-27 |
30-day Notice |
| S024 |
2020-12-10 |
30-day Notice |
| S023 |
2020-04-29 |
135 Review Track For 30-day Notice |
| S022 |
2020-03-13 |
Real-time Process |
| S021 |
2019-12-27 |
30-day Notice |
| S020 |
2019-10-08 |
30-day Notice |
| S019 |
2019-08-15 |
30-day Notice |
| S018 |
2019-05-22 |
30-day Notice |
| S017 |
2019-04-22 |
30-day Notice |
| S016 |
2019-04-15 |
30-day Notice |
| S015 |
2019-02-11 |
30-day Notice |
| S014 |
2019-02-04 |
Special (immediate Track) |
| S013 |
2018-12-13 |
30-day Notice |
| S012 |
2018-10-30 |
30-day Notice |
| S011 |
2018-09-10 |
30-day Notice |
| S010 |
2018-08-27 |
30-day Notice |
| S009 |
2018-08-14 |
135 Review Track For 30-day Notice |
| S008 |
2018-07-09 |
30-day Notice |
| S007 |
2018-07-02 |
Normal 180 Day Track |
| S006 |
2018-06-29 |
Special (immediate Track) |
| S005 |
2018-06-15 |
30-day Notice |
| S004 |
2018-05-17 |
30-day Notice |
| S003 |
2018-04-12 |
30-day Notice |
| S002 |
2018-03-13 |
30-day Notice |
| S001 |
2018-02-23 |
Real-time Process |
NIH GUDID Devices