Approval for the arista ah absorbable hemostat. The device is indicated for use in surgical procedures (except neurological, ophthalmic, and urological) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
| Device | ARISTA AH ABSORBABLE HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 2005-09-30 |
| Decision Date | 2006-09-26 |
| Notice Date | 2006-10-03 |
| PMA | P050038 |
| Supplement | S |
| Product Code | LMG |
| Docket Number | 06M-0396 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | C.R. Bard, Inc. 160 New Boston Street woburn, MA 01801 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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