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.
A change in bacterial endotoxin test sampling plan and to update the manufacturing procedure to conduct bacterial endotoxin testing prior to device sterilization
| Device | (WEB) Aneurysm Embolization System |
| Generic Name | Intrasaccular Flow Disruption Device |
| Applicant | MicroVention, Inc. |
| Date Received | 2021-11-22 |
| Decision Date | 2021-12-20 |
| PMA | P170032 |
| Supplement | S010 |
| Product Code | OPR |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroVention, Inc. 35 Enterprise aliso Viejo, CA 92656 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170032 | Original Filing | |
| S011 | 2021-12-20 | 30-day Notice |
| S010 | 2021-11-22 | 30-day Notice |
| S009 | 2021-07-26 | Real-time Process |
| S008 | 2021-05-06 | 30-day Notice |
| S007 | ||
| S006 | 2020-04-06 | 30-day Notice |
| S005 | 2019-12-26 | 30-day Notice |
| S004 | ||
| S003 | ||
| S002 | 2019-04-05 | Normal 180 Day Track No User Fee |
| S001 |