Approval for the addition of a new trade name. The device, as modified, will be marketed under the trade name vitasure and is indicated for use in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arterial 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 | 2008-06-17 |
| Decision Date | 2008-07-02 |
| PMA | P050038 |
| Supplement | S007 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | C.R. Bard, Inc. 160 New Boston Street woburn, MA 01801 |
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