Approval for manufacturing modifications to the avitene ultrafoam cast microfibrillar collagen hemostat (mch) sponge and modifications to the labeling. The device, as modified, will be marketed under the trade name avitene ultrawrap collagen hemostat and is indicated for use in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Device | AVITENE ULTRA WRAP COLLAGEN HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. |
| Date Received | 2001-10-18 |
| Decision Date | 2001-12-06 |
| PMA | N17600 |
| Supplement | S019 |
| Product Code | LMF |
| 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., SUB. C.R. BARD, INC. 100 Crossings Boulevard warwick, RI 02886 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| N17600 | | Original Filing |
| S035 |
2021-01-19 |
30-day Notice |
| S034 | | |
| S033 |
2020-02-28 |
30-day Notice |
| S032 |
2019-05-20 |
30-day Notice |
| S031 |
2018-12-03 |
30-day Notice |
| S030 |
2018-06-28 |
30-day Notice |
| S029 |
2014-05-30 |
30-day Notice |
| S028 |
2013-06-24 |
30-day Notice |
| S027 |
2013-05-28 |
30-day Notice |
| S026 |
2011-12-22 |
Special (immediate Track) |
| S025 |
2011-09-02 |
30-day Notice |
| S024 |
2009-03-20 |
30-day Notice |
| S023 |
2005-09-08 |
30-day Notice |
| S022 | | |
| S021 |
2004-10-04 |
30-day Notice |
| S020 |
2003-06-11 |
30-day Notice |
| S019 |
2001-10-18 |
Real-time Process |
| S018 |
2001-05-23 |
30-day Notice |
| S017 |
2000-12-14 |
Normal 180 Day Track |
| S016 |
1998-12-21 |
Real-time Process |
| S015 |
1998-07-21 |
30-day Notice |
| S014 |
1995-03-16 |
Normal 180 Day Track |
| S013 |
1995-01-23 |
Normal 180 Day Track |
| S012 |
1994-06-07 |
Normal 180 Day Track |
| S011 |
1993-08-23 |
Normal 180 Day Track |
| S010 |
1991-10-07 |
Normal 180 Day Track |
| S009 |
1986-09-16 |
Special (immediate Track) |
| S008 |
1983-08-26 |
|
| S007 |
1982-02-02 |
|
| S006 | | |
| S005 |
1981-08-20 |
|
| S004 |
1980-07-21 |
|
| S003 |
1980-07-08 |
|
| S002 |
1980-06-16 |
|
| S001 |
1980-01-28 |
|
NIH GUDID Devices