Approval for the bioflue surgical adhesive. This device is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral and carotid arteries).
| Device | BIOGLUE SURGICAL ADHESIVE |
| Classification Name | Glue, Surgical, Arteries |
| Generic Name | Glue, Surgical, Arteries |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2001-02-02 |
| Decision Date | 2001-12-03 |
| Notice Date | 2001-12-20 |
| PMA | P010003 |
| Supplement | S |
| Product Code | MUQ |
| Docket Number | 01M-0567 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010003 | | Original Filing |
| S040 |
2022-04-29 |
30-day Notice |
| S039 |
2021-11-12 |
30-day Notice |
| S038 |
2021-06-25 |
30-day Notice |
| S037 |
2019-11-27 |
30-day Notice |
| S036 |
2019-07-23 |
30-day Notice |
| S035 | | |
| S034 | | |
| S033 | | |
| S032 |
2018-12-07 |
30-day Notice |
| S031 |
2018-10-02 |
Special (immediate Track) |
| S030 |
2018-05-29 |
30-day Notice |
| S029 |
2017-12-05 |
30-day Notice |
| S028 |
2017-08-14 |
30-day Notice |
| S027 |
2017-07-24 |
Special (immediate Track) |
| S026 | | |
| S025 |
2016-08-22 |
30-day Notice |
| S024 |
2016-06-14 |
30-day Notice |
| S023 |
2016-04-07 |
135 Review Track For 30-day Notice |
| S022 |
2016-04-04 |
30-day Notice |
| S021 |
2016-03-25 |
30-day Notice |
| S020 |
2016-03-08 |
30-day Notice |
| S019 |
2015-08-27 |
30-day Notice |
| S018 | | |
| S017 |
2013-08-08 |
30-day Notice |
| S016 |
2012-01-10 |
Real-time Process |
| S015 |
2010-04-30 |
Special (immediate Track) |
| S014 |
2009-05-14 |
Real-time Process |
| S013 |
2008-09-16 |
Special (immediate Track) |
| S012 |
2008-06-06 |
30-day Notice |
| S011 |
2007-08-06 |
Real-time Process |
| S010 |
2007-04-20 |
Real-time Process |
| S009 |
2007-01-16 |
Special (immediate Track) |
| S008 |
2006-06-26 |
30-day Notice |
| S007 |
2005-10-31 |
Normal 180 Day Track |
| S006 |
2005-07-25 |
Normal 180 Day Track No User Fee |
| S005 |
2005-04-14 |
Real-time Process |
| S004 |
2004-09-21 |
Special (immediate Track) |
| S003 |
2004-03-17 |
Real-time Process |
| S002 |
2002-09-19 |
Normal 180 Day Track |
| S001 |
2002-05-03 |
135 Review Track For 30-day Notice |
NIH GUDID Devices