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 the pipeline flex embolization device to expand the indications for use to include use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2. 0 mm and
| Device | Pipeline Flex Embolization |
| Classification Name | Intracranial Aneurysm Flow Diverter |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
| Date Received | 2017-06-28 |
| Decision Date | 2018-12-14 |
| Notice Date | 2019-01-25 |
| PMA | P100018 |
| Supplement | S015 |
| Product Code | OUT |
| Docket Number | 18M-4779 |
| Advisory Committee | Neurology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100018 | Original Filing | |
| S037 | 2022-08-09 | Real-time Process |
| S036 | 2021-12-08 | 30-day Notice |
| S035 | ||
| S034 | ||
| S033 | 2021-07-12 | 30-day Notice |
| S032 | 2021-04-30 | Normal 180 Day Track No User Fee |
| S031 | 2021-02-19 | 30-day Notice |
| S030 | 2020-11-27 | 30-day Notice |
| S029 | ||
| S028 | 2020-08-24 | Special (immediate Track) |
| S027 | 2020-06-02 | 30-day Notice |
| S026 | ||
| S025 | ||
| S024 | ||
| S023 | 2019-08-22 | 30-day Notice |
| S022 | ||
| S021 | 2019-07-05 | 30-day Notice |
| S020 | 2019-04-26 | 30-day Notice |
| S019 | 2018-11-29 | 30-day Notice |
| S018 | 2018-09-24 | 30-day Notice |
| S017 | 2017-12-15 | Normal 180 Day Track No User Fee |
| S016 | 2017-09-14 | 30-day Notice |
| S015 | 2017-06-28 | Panel Track |
| S014 | 2016-03-03 | 30-day Notice |
| S013 | 2014-10-06 | Special (immediate Track) |
| S012 | 2014-07-21 | 30-day Notice |
| S011 | 2014-06-26 | Normal 180 Day Track |
| S010 | 2014-01-28 | 30-day Notice |
| S009 | ||
| S008 | 2013-07-22 | Real-time Process |
| S007 | 2013-04-11 | 30-day Notice |
| S006 | 2013-03-12 | 30-day Notice |
| S005 | 2012-12-21 | Special (immediate Track) |
| S004 | 2011-09-19 | Normal 180 Day Track No User Fee |
| S003 | 2011-08-01 | Special (immediate Track) |
| S002 | ||
| S001 | 2011-04-28 | Normal 180 Day Track No User Fee |