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 adding a warning about allergies to metals used in the device and clarifying your instructions for uese.
Device | PIPELINE EMBOLIZATION DEVICE |
Generic Name | Intracranial Aneurysm Flow Diverter |
Applicant | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
Date Received | 2011-08-01 |
Decision Date | 2011-08-30 |
PMA | P100018 |
Supplement | S003 |
Product Code | OUT |
Advisory Committee | Neurology |
Supplement Type | Special (immediate Track) |
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 |