Three changes to the non-patient contacting introducer sheath component of the neuroform atlas stent system: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; 3) tip length specification simplification and change of the nominal length
| Device | Neuroform Atlas® Stent System |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | Stryker Neurovascular |
| Date Received | 2022-01-12 |
| Decision Date | 2022-02-07 |
| PMA | P180031 |
| Supplement | S004 |
| Product Code | QCA |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Stryker Neurovascular 47900 Bayside Parkway fremont, CA 94538 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180031 | | Original Filing |
| S005 |
2022-09-20 |
30-day Notice |
| S004 |
2022-01-12 |
30-day Notice |
| S003 |
2020-08-04 |
30-day Notice |
| S002 |
2019-08-21 |
Normal 180 Day Track No User Fee |
| S001 | | |
NIH GUDID Devices