Change to the frequency of the bioburden assessments from quarterly to annually for bioglue accessories that undergo ethylene oxide (eo) sterilization, a modification to the limulus amebocyte lysate (lal) test method for bioglue to include agitation during the extraction process and change the dilution to test the bioglue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of certificates of completion for the autoclaves used in production and microbiology.
| Device | BIOGLUE SURGICAL ADHESIVE |
| Classification Name | Glue, Surgical, Arteries |
| Generic Name | Glue, Surgical, Arteries |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2016-04-04 |
| Decision Date | 2016-05-04 |
| PMA | P010003 |
| Supplement | S022 |
| Product Code | MUQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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