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 of the protocol for the post-approval study (pas) protocol.
| Device | AMPLATZER PFO OCCLUDER |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2016-11-23 |
| Decision Date | 2017-09-22 |
| PMA | P120021 |
| Supplement | S002 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |