Approval of the hemoblast bellows. This device is indicated for surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
| 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 | 2017-03-30 |
| Decision Date | 2017-12-15 |
| Notice Date | 2017-12-18 |
| PMA | P170012 |
| Supplement | S |
| Product Code | PMX |
| Docket Number | 17M-6896 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biom'Up SA 120 Brimful Drive phoenixville, PA 19460 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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