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.
| Device | Flow Re-Direction Endoluminal (FRED®) System, FREDX System |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | MicroVention, Inc.35 Enterpricsealiso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS007 Date Received01/31/2022 Decision Date03/01/2022 Product Code OUT Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-03-01 |
| PMA | P180027 |
| Supplement | S007 |
| 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 | MicroVention, Inc. 35 Enterpricse aliso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS007 Date Received01/31/2022 Decision Date03/01/2022 Product Code OUT Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement relocation Of The Supplier Of Several Flow Re-Direction Endoluminal Device (FRED) System And FRED X System Components, Creganna Medical, From The Manufacturing Location In Tualatin, Oregon, To Wilsonville, Oregon, And Heredia, Costa Rica |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180027 | Original Filing | |
| S008 | 2022-03-07 | 30-day Notice |
| S007 | 2022-01-31 | 30-day Notice |
| S006 | 2021-11-23 | Real-time Process |
| S005 | ||
| S004 | 2021-05-03 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2020-06-19 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00842429114490 | P180027 | 002 |
| 00842429114339 | P180027 | 002 |
| 00842429114322 | P180027 | 002 |
| 00842429114315 | P180027 | 002 |
| 00842429114308 | P180027 | 002 |
| 00842429114292 | P180027 | 002 |
| 00842429114285 | P180027 | 002 |
| 00842429114278 | P180027 | 002 |
| 00842429114261 | P180027 | 002 |
| 00842429114254 | P180027 | 002 |
| 00842429114247 | P180027 | 002 |
| 00842429114230 | P180027 | 002 |
| 00842429114223 | P180027 | 002 |
| 00842429114346 | P180027 | 002 |
| 00842429114353 | P180027 | 002 |
| 00842429114360 | P180027 | 002 |
| 00842429114483 | P180027 | 002 |
| 00842429114476 | P180027 | 002 |
| 00842429114469 | P180027 | 002 |
| 00842429114452 | P180027 | 002 |
| 00842429114445 | P180027 | 002 |
| 00842429114438 | P180027 | 002 |
| 00842429114421 | P180027 | 002 |
| 00842429114414 | P180027 | 002 |
| 00842429114407 | P180027 | 002 |
| 00842429114391 | P180027 | 002 |
| 00842429114384 | P180027 | 002 |
| 00842429114377 | P180027 | 002 |
| 00842429114216 | P180027 | 002 |