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 | Neuroform Atlas® Stent System |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | Stryker Neurovascular47900 Bayside Parkwayfremont, CA 94538 PMA NumberP180031 Supplement NumberS005 Date Received09/20/2022 Decision Date11/15/2022 Product Code QCA Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-20 |
| Decision Date | 2022-11-15 |
| PMA | P180031 |
| Supplement | S005 |
| 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 PMA NumberP180031 Supplement NumberS005 Date Received09/20/2022 Decision Date11/15/2022 Product Code QCA Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For A Change To The In-process Specification Of The Inner Diameter Of The Nitinol Stent Component Of The Neuroform Atlas Stent System |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 07613327382235 | P180031 | 000 |
| 07613327382136 | P180031 | 000 |
| 07613327382143 | P180031 | 000 |
| 07613327382150 | P180031 | 000 |
| 07613327382167 | P180031 | 000 |
| 07613327382174 | P180031 | 000 |
| 07613327382181 | P180031 | 000 |
| 07613327382198 | P180031 | 000 |
| 07613327382204 | P180031 | 000 |
| 07613327382211 | P180031 | 000 |
| 07613327382228 | P180031 | 000 |
| 07613327382129 | P180031 | 000 |