This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | BioGlue Surgical Adhesive |
| Generic Name | Glue, Surgical, Arteries |
| Applicant | CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP010003 Supplement NumberS040 Date Received04/29/2022 Decision Date05/25/2022 Product Code MUQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-05-25 |
| PMA | P010003 |
| Supplement | S040 |
| 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 PMA NumberP010003 Supplement NumberS040 Date Received04/29/2022 Decision Date05/25/2022 Product Code MUQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Alternative Irradiation Box And Configuration For Shipping Product, And A New Supplier For The Strong Ammonium Solution |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 10877234001311 | P010003 | 001 |
| 20877234001301 | P010003 | 001 |
| 20877234001295 | P010003 | 001 |
| 00877234000232 | P010003 | 001 |
| 00877234000249 | P010003 | 001 |
| 10877234000253 | P010003 | 001 |
| 10877234000192 | P010003 | 005 |
| 10877234000918 | P010003 | 005 |
| 10877234000925 | P010003 | 005 |
| 10877234000154 | P010003 | 005 |
| 10877234001182 | P010003 | 005 |
| 00877234000188 | P010003 | 005 |
| 10877234000901 | P010003 | 006 |
| 10877234000895 | P010003 | 006 |
| 00877234000164 | P010003 | 006 |
| 10877234000178 | P010003 | 006 |
| 10877234000949 | P010003 | 016 |
| 10877234000932 | P010003 | 016 |
| 10877234000260 | P010003 | 016 |
| 00877234000270 | P010003 | 016 |