Changes to the porcine collagen powder (pow04) production process in order to increase the manufacturing capacity of the component. Changes include duplicating existing equipment and optimizing the production process in order to decrease the overall time needed to manufacture a batch of pow04
| Device | HEMOBLAST Bellows |
| Classification Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | Biom'Up SA |
| Date Received | 2019-02-11 |
| Decision Date | 2019-03-13 |
| PMA | P170012 |
| Supplement | S015 |
| Product Code | PMX |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biom'Up SA 120 Brimful Drive phoenixville, PA 19460 |
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