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 changes to the packaging operations of the pipeline flex embolization device, including the addition of a new pouch heat sealer and replacing quality control visual inspections with equivalent in-line inspections
| Device | Pipeline Flex Embolization |
| Classification Name | Intracranial Aneurysm Flow Diverter |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
| Date Received | 2019-08-22 |
| Decision Date | 2019-09-20 |
| PMA | P100018 |
| Supplement | S023 |
| Product Code | OUT |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618 |
| 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 |