Elimination of certain in process or final device tests performed on avitene(r) collagen hemostasis (mch) products. This will eliminate test redundancy, waste and/or provide a more efficient utilization of test samples selected during the processing of avitene.
| Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. |
| Date Received | 2001-05-23 |
| Decision Date | 2001-06-18 |
| PMA | N17600 |
| Supplement | S018 |
| 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 | 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