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 | SURGIFOAM Absorabable Gelatin Sponge, U.S.P., SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic MatrixKit with Thrombin |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | Ferrosan Meidcal Devices A/Ssydmarken 5soeborg 08876 PMA NumberP990004 Supplement NumberS055 Date Received06/27/2022 Decision Date12/21/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-12-21 |
| PMA | P990004 |
| Supplement | S055 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Ferrosan Meidcal Devices A/S sydmarken 5 soeborg 08876 PMA NumberP990004 Supplement NumberS055 Date Received06/27/2022 Decision Date12/21/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For An Additional Sterilization Chamber To Be Used For Gamma Irradiation At The Current Gamma Sterilization Site |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990004 | Original Filing | |
| S056 | 2022-07-01 | 135 Review Track For 30-day Notice |
| S055 | 2022-06-27 | 135 Review Track For 30-day Notice |
| S054 | 2022-03-07 | 30-day Notice |
| S053 | 2021-12-23 | 30-day Notice |
| S052 | 2021-12-20 | 30-day Notice |
| S051 | 2021-11-22 | 30-day Notice |
| S050 | 2021-09-28 | 30-day Notice |
| S049 | 2021-07-26 | Special (immediate Track) |
| S048 | 2021-05-03 | 30-day Notice |
| S047 | 2021-04-02 | 30-day Notice |
| S046 | ||
| S045 | ||
| S044 | ||
| S043 | 2020-08-26 | 30-day Notice |
| S042 | 2020-07-30 | Special (immediate Track) |
| S041 | 2020-06-24 | 30-day Notice |
| S040 | 2020-06-08 | 30-day Notice |
| S039 | ||
| S038 | 2020-03-19 | 30-day Notice |
| S037 | 2020-02-18 | 30-day Notice |
| S036 | 2019-10-01 | Special (immediate Track) |
| S035 | 2019-02-04 | 135 Review Track For 30-day Notice |
| S034 | ||
| S033 | 2018-09-05 | 135 Review Track For 30-day Notice |
| S032 | 2017-08-25 | 30-day Notice |
| S031 | 2017-05-04 | 30-day Notice |
| S030 | 2017-02-09 | 30-day Notice |
| S029 | 2016-01-27 | 30-day Notice |
| S028 | 2015-03-06 | Normal 180 Day Track No User Fee |
| S027 | 2015-02-18 | 30-day Notice |
| S026 | 2015-02-18 | 30-day Notice |
| S025 | 2014-10-24 | Normal 180 Day Track |
| S024 | 2014-04-22 | Normal 180 Day Track No User Fee |
| S023 | 2012-10-22 | 135 Review Track For 30-day Notice |
| S022 | 2012-06-18 | Special (immediate Track) |
| S021 | 2011-02-04 | 30-day Notice |
| S020 | ||
| S019 | 2010-10-18 | Normal 180 Day Track |
| S018 | 2010-06-23 | Real-time Process |
| S017 | 2010-03-02 | Real-time Process |
| S016 | 2009-07-06 | Real-time Process |
| S015 | 2008-09-03 | 30-day Notice |
| S014 | 2008-06-27 | 30-day Notice |
| S013 | 2007-07-05 | Normal 180 Day Track |
| S012 | 2007-06-20 | Normal 180 Day Track |
| S011 | 2007-03-19 | Real-time Process |
| S010 | 2006-08-30 | Real-time Process |
| S009 | 2005-12-20 | Real-time Process |
| S008 | 2005-03-10 | Real-time Process |
| S007 | 2004-11-16 | Normal 180 Day Track No User Fee |
| S006 | 2004-05-10 | Real-time Process |
| S005 | 2004-01-26 | Normal 180 Day Track No User Fee |
| S004 | 2002-08-23 | Real-time Process |
| S003 | 2000-10-02 | Real-time Process |
| S002 | 1999-11-16 | Real-time Process |
| S001 | 1999-11-15 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 15712123000158 | P990004 | 001 |
| 15712123000172 | P990004 | 002 |
| 15712123000189 | P990004 | 002 |
| 15712123000202 | P990004 | 002 |
| 15712123000226 | P990004 | 003 |
| 15712123000264 | P990004 | 004 |
| 15712123000240 | P990004 | 004 |
| 15712123000325 | P990004 | 008 |
| 15712123000288 | P990004 | 008 |
| 15712123000318 | P990004 | 008 |
| 15712123000141 | P990004 | 010 |