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 | VenaSeal ™ Closure System |
| Generic Name | Agent, Occluding, Vascular, Permanent |
| Applicant | MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS034 Date Received08/15/2022 Decision Date09/13/2022 Product Code PJQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-15 |
| Decision Date | 2022-09-13 |
| PMA | P140018 |
| Supplement | S034 |
| Product Code | PJQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441 PMA NumberP140018 Supplement NumberS034 Date Received08/15/2022 Decision Date09/13/2022 Product Code PJQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change To The Bioburden Action And Alert Limits For The VenaSeal Closure System |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140018 | Original Filing | |
| S036 | 2022-11-29 | 30-day Notice |
| S035 | 2022-10-12 | 30-day Notice |
| S034 | 2022-08-15 | 30-day Notice |
| S033 | ||
| S032 | 2022-04-29 | Real-time Process |
| S031 | 2022-01-21 | 30-day Notice |
| S030 | 2021-11-30 | 30-day Notice |
| S029 | ||
| S028 | 2021-09-23 | 30-day Notice |
| S027 | ||
| S026 | ||
| S025 | 2021-04-23 | Special (immediate Track) |
| S024 | ||
| S023 | 2021-02-25 | 30-day Notice |
| S022 | ||
| S021 | 2020-10-19 | Real-time Process |
| S020 | 2020-08-24 | 30-day Notice |
| S019 | 2020-03-10 | Special (immediate Track) |
| S018 | 2019-10-28 | Normal 180 Day Track |
| S017 | 2019-09-25 | Real-time Process |
| S016 | 2019-08-09 | 30-day Notice |
| S015 | 2019-05-24 | 30-day Notice |
| S014 | 2018-11-16 | 30-day Notice |
| S013 | 2018-09-24 | 30-day Notice |
| S012 | 2018-08-10 | 30-day Notice |
| S011 | 2018-03-27 | 30-day Notice |
| S010 | 2018-03-05 | 30-day Notice |
| S009 | 2018-02-26 | 30-day Notice |
| S008 | 2017-08-04 | Normal 180 Day Track |
| S007 | 2017-06-13 | Special (immediate Track) |
| S006 | 2017-05-18 | Normal 180 Day Track No User Fee |
| S005 | 2016-11-01 | 30-day Notice |
| S004 | 2016-09-07 | Normal 180 Day Track No User Fee |
| S003 | 2016-07-26 | 30-day Notice |
| S002 | 2016-06-27 | 30-day Notice |
| S001 | 2015-07-28 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 10884521539921 | P140018 | 000 |
| 20643169986262 | P140018 | 006 |
| 00763000240776 | P140018 | 018 |