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.
The addition of braiding and furnace equipment for the fred implant at the microvention costa rica facility
| Device | Flow Re-Direction Endoluminal (FRED) System |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | MicroVention Terumo |
| Date Received | 2020-06-19 |
| Decision Date | 2020-07-17 |
| PMA | P180027 |
| Supplement | S001 |
| 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 Terumo 35 Enterpricse aliso Viejo, CA 92765 |
| 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 |