Approval for the line extension of the flexitip xl applicator family to include the flexitip xl-r applicator. The modification is based upon the current applicator design but now includes an additional outer stainless steel tubing to create a rigid (xl-r) portion of the applicator tip. In addition, approval for revision of the instructions for use of the arista ah product labeling in order to inform users of use of the new applicator during endoscopic/ laparoscopic uses.
| Device | ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 2014-07-29 |
| Decision Date | 2015-03-16 |
| PMA | P050038 |
| Supplement | S023 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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