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.
Modifications to hypotube tensile strength test of pipeline flex embolization device and pipeline flex embolization device with shield technology, using an in-process manufacturing acceptance criteria of >= 3. 0 n for the test, and shifting the hypotube tensile strength test from the final inspection step to an earlier subassembly step
| Device | Pipeline Flex Embolization and Pipeline Flex Embolization with Shield Technology |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR |
| Date Received | 2021-07-12 |
| Decision Date | 2021-07-27 |
| PMA | P100018 |
| Supplement | S033 |
| 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, 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 |