Foil pouch supplier facility site change and the proposed removal of a rejection criterion for component acceptance in an in-process inspection step for the avitene product family.
| Device | AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 2014-05-30 |
| Decision Date | 2014-06-26 |
| PMA | P800002 |
| Supplement | S021 |
| 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