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 revised protocol for the post-approval study (pas) pipeline flex embolization w/shield tech pas. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p100018/s026.
| Device | Pipeline Flex Embolization with Shield Technology |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR |
| Date Received | 2021-04-30 |
| Decision Date | 2021-07-19 |
| PMA | P100018 |
| Supplement | S032 |
| Product Code | OUT |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Micro Therapeutics, Inc. D/b/a 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 |