Approval for a disposable dual-barrel piston-driven syringe dispensing system as an alternate to the current dual-barrel reusable ratcheting piston-driven cartridge system. The device, as modified, will be marketed under the trade name bg3500 and 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 IN SYRINGE DELIVERY SYSTEM (MODEL BG3500) |
| Classification Name | Glue, Surgical, Arteries |
| Generic Name | Glue, Surgical, Arteries |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2004-03-17 |
| Decision Date | 2004-05-03 |
| PMA | P010003 |
| Supplement | S003 |
| Product Code | MUQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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