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 | EXOSEAL® Vascular Closure |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS026 Date Received10/21/2022 Decision Date10/28/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-21 |
| Decision Date | 2022-10-28 |
| PMA | P100013 |
| Supplement | S026 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis US Corporation 14201 N.w. 60th Avenue miami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS026 Date Received10/21/2022 Decision Date10/28/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement for A Change To Paper Weight Used With For The EXOSEAL® IFU From 50 Lb To 40 Lb At Steri-Tek |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100013 | Original Filing | |
| S026 | 2022-10-21 | 30-day Notice |
| S025 | ||
| S024 | 2022-01-31 | 30-day Notice |
| S023 | 2021-11-17 | 30-day Notice |
| S022 | 2021-10-27 | 30-day Notice |
| S021 | 2021-09-10 | 30-day Notice |
| S020 | 2019-05-24 | 30-day Notice |
| S019 | 2019-04-05 | 30-day Notice |
| S018 | 2019-02-28 | 30-day Notice |
| S017 | 2018-07-12 | 30-day Notice |
| S016 | ||
| S015 | 2017-08-11 | Normal 180 Day Track No User Fee |
| S014 | 2017-04-11 | 135 Review Track For 30-day Notice |
| S013 | 2016-06-02 | 30-day Notice |
| S012 | 2015-07-23 | 30-day Notice |
| S011 | ||
| S010 | 2014-03-24 | 30-day Notice |
| S009 | 2013-04-09 | 30-day Notice |
| S008 | 2012-12-03 | 30-day Notice |
| S007 | 2012-11-13 | 30-day Notice |
| S006 | 2012-09-13 | 30-day Notice |
| S005 | 2012-07-16 | 30-day Notice |
| S004 | 2012-06-19 | 30-day Notice |
| S003 | 2011-12-12 | Real-time Process |
| S002 | 2011-08-30 | 30-day Notice |
| S001 | 2011-07-28 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 20705032058893 | P100013 | 010 |
| 20705032058879 | P100013 | 010 |
| 20705032058855 | P100013 | 010 |