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 | HEMOBLAST™ Bellows |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | Biom'Up France SAS8 Allee Irene Joliot Curiesaint-priest 69800 PMA NumberP170012 Supplement NumberS028 Date Received11/23/2021 Decision Date04/22/2022 Product Code PMX Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2021-11-23 |
| Decision Date | 2022-04-22 |
| PMA | P170012 |
| Supplement | S028 |
| 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 PMA NumberP170012 Supplement NumberS028 Date Received11/23/2021 Decision Date04/22/2022 Product Code PMX Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement approval For The Modification Of The Blending Method For The Three Constituent Components That Compose The Finished HEMOBLAST™ Bellows Hemostatic Powder In The Manufacturing Process |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 03760193182705 | P170012 | 000 |
| 03760193182668 | P170012 | 007 |