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.
Approval for an alternate sterilization site located at sterigenics, 5725 harold gatty drive, salt lake city, utah, 84116.
| Device | AMPLATZER PFO Occluder |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2019-02-15 |
| Decision Date | 2019-03-05 |
| PMA | P120021 |
| Supplement | S010 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120021 | Original Filing | |
| S023 | 2021-11-26 | Normal 180 Day Track No User Fee |
| S022 | ||
| S021 | 2021-06-28 | 30-day Notice |
| S020 | ||
| S019 | ||
| S018 | 2020-05-06 | 30-day Notice |
| S017 | 2020-04-24 | 30-day Notice |
| S016 | ||
| S015 | 2020-03-19 | 30-day Notice |
| S014 | 2020-03-17 | 30-day Notice |
| S013 | 2019-09-26 | 30-day Notice |
| S012 | 2019-06-24 | Normal 180 Day Track No User Fee |
| S011 | 2019-02-27 | 30-day Notice |
| S010 | 2019-02-15 | Normal 180 Day Track No User Fee |
| S009 | 2019-01-03 | 30-day Notice |
| S008 | ||
| S007 | 2018-02-12 | 30-day Notice |
| S006 | 2018-01-30 | Real-time Process |
| S005 | ||
| S004 | 2017-07-06 | 30-day Notice |
| S003 | 2017-01-26 | 30-day Notice |
| S002 | 2016-11-23 | Normal 180 Day Track No User Fee |
| S001 | 2016-11-17 | Normal 180 Day Track No User Fee |