Use of an alternative biological indicator (bi) for use in sterilization of the venaseal closure system
| Device | VenaSeal Closure System |
| Generic Name | Agent, Occluding, Vascular, Permanent |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2021-09-23 |
| Decision Date | 2021-10-06 |
| PMA | P140018 |
| Supplement | S028 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices