Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of avitene mch flour, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.
| Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 1998-07-21 |
| Decision Date | 1998-08-10 |
| PMA | P800002 |
| Supplement | S011 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |
|---|
| P800002 | | Original Filing |
| S028 |
2021-01-19 |
30-day Notice |
| S027 | | |
| S026 |
2020-02-28 |
30-day Notice |
| S025 |
2019-05-20 |
30-day Notice |
| S024 |
2018-12-03 |
30-day Notice |
| S023 |
2018-06-28 |
30-day Notice |
| S022 |
2017-03-27 |
135 Review Track For 30-day Notice |
| S021 |
2014-05-30 |
30-day Notice |
| S020 |
2013-12-11 |
30-day Notice |
| S019 |
2013-06-24 |
30-day Notice |
| S018 |
2011-12-22 |
Special (immediate Track) |
| S017 |
2011-09-02 |
30-day Notice |
| S016 |
2009-03-20 |
30-day Notice |
| S015 |
2005-09-08 |
30-day Notice |
| S014 |
2004-10-04 |
30-day Notice |
| S013 |
2003-06-11 |
30-day Notice |
| S012 |
2001-05-23 |
30-day Notice |
| S011 |
1998-07-21 |
30-day Notice |
| S010 |
1993-12-02 |
Normal 180 Day Track |
| S009 |
1992-01-21 |
Normal 180 Day Track |
| S008 |
1991-10-16 |
Normal 180 Day Track |
| S007 |
1988-03-08 |
Normal 180 Day Track |
| S006 | | |
| S005 |
1983-10-11 |
|
| S004 |
1983-08-30 |
|
| S003 |
1982-01-07 |
|
| S002 |
1981-01-27 |
|
| S001 |
1981-04-09 |
|
NIH GUDID Devices