Approval for a change to the instructions for use on the cardiotomy filter size range to include a 20-40 micron size range for autologous blood salvage systems compatible with the device.
| Device | Arista AH Absorbable Hemostatic Particles |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | Davol, Inc. |
| Date Received | 2020-02-24 |
| Decision Date | 2020-04-29 |
| PMA | P050038 |
| Supplement | S035 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Davol, Inc. 100 Crossings Boulevard warwick, RI 02886 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050038 | | Original Filing |
| S039 |
2021-05-24 |
Real-time Process |
| S038 | | |
| S037 |
2020-10-02 |
Normal 180 Day Track No User Fee |
| S036 |
2020-08-26 |
Special (immediate Track) |
| S035 |
2020-02-24 |
Real-time Process |
| S034 |
2019-10-21 |
30-day Notice |
| S033 | | |
| S032 |
2018-08-01 |
135 Review Track For 30-day Notice |
| S031 | | |
| S030 |
2016-06-17 |
Normal 180 Day Track |
| S029 |
2016-02-23 |
30-day Notice |
| S028 |
2015-12-09 |
30-day Notice |
| S027 |
2015-11-02 |
30-day Notice |
| S026 |
2015-08-10 |
30-day Notice |
| S025 |
2015-07-02 |
30-day Notice |
| S024 |
2015-05-27 |
30-day Notice |
| S023 |
2014-07-29 |
Normal 180 Day Track |
| S022 |
2014-04-29 |
Normal 180 Day Track No User Fee |
| S021 |
2014-02-19 |
30-day Notice |
| S020 |
2014-02-11 |
30-day Notice |
| S019 |
2013-12-13 |
Real-time Process |
| S018 |
2013-05-31 |
30-day Notice |
| S017 |
2013-04-08 |
Normal 180 Day Track No User Fee |
| S016 |
2013-03-07 |
30-day Notice |
| S015 |
2013-02-22 |
30-day Notice |
| S014 | | |
| S013 |
2012-12-13 |
30-day Notice |
| S012 |
2012-12-10 |
30-day Notice |
| S011 |
2012-02-22 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2008-08-29 |
30-day Notice |
| S007 |
2008-06-17 |
Normal 180 Day Track No User Fee |
| S006 |
2008-06-03 |
30-day Notice |
| S005 |
2008-05-09 |
Normal 180 Day Track No User Fee |
| S004 |
2007-11-16 |
Normal 180 Day Track No User Fee |
| S003 |
2007-08-30 |
30-day Notice |
| S002 |
2007-05-07 |
Normal 180 Day Track No User Fee |
| S001 |
2007-05-01 |
Normal 180 Day Track |
NIH GUDID Devices