This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the amplatzer pfo occluder. The device is indicated for percutaneous transcatheter closure of a patent foramen ovale (pfo) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
| Device | AMPLATZER PFO OCCLUDER |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2012-11-30 |
| Decision Date | 2016-10-28 |
| Notice Date | 2016-11-01 |
| PMA | P120021 |
| Supplement | S |
| Product Code | MLV |
| Docket Number | 16M-3653 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |