Approval for clarification regarding one of the warnings in the instructions for use (ifu).
| Device | BIOGLUE SURGICAL ADHESIVE |
| Classification Name | Glue, Surgical, Arteries |
| Generic Name | Glue, Surgical, Arteries |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2010-04-30 |
| Decision Date | 2010-05-12 |
| PMA | P010003 |
| Supplement | S015 |
| Product Code | MUQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144 |
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