Approval for the addition of a precautions section to the instructions for use for the avitene family of products. The additional language is as follows: "any excess avitene mch not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that maypresent with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon conclusion ofthe initial procedure, typically resolves all signs and symptoms. "
| Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 2011-12-22 |
| Decision Date | 2012-01-23 |
| PMA | P800002 |
| Supplement | S018 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| 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 |
|---|
| 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