Sterilization site change have been reviewed and are acceptable. All information, including process validation, supports that the procedures meet the requirements of 21 cfr 820.
| Device | Superion Indirect Decompression System |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | Boston Scientific Neuromodulation |
| Date Received | 2021-12-03 |
| Decision Date | 2022-02-08 |
| PMA | P140004 |
| Supplement | S027 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Neuromodulation 25155 Rye Canyon Loop valencia, CA 91355 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140004 | | Original Filing |
| S029 |
2022-12-08 |
30-day Notice |
| S028 |
2021-12-03 |
Real-time Process |
| S027 |
2021-12-03 |
Normal 180 Day Track No User Fee |
| S026 |
2021-09-07 |
30-day Notice |
| S025 |
2021-07-30 |
30-day Notice |
| S024 |
2020-08-24 |
Normal 180 Day Track No User Fee |
| S023 |
2020-08-24 |
30-day Notice |
| S022 | | |
| S021 |
2020-08-24 |
30-day Notice |
| S020 | | |
| S019 |
2020-07-20 |
30-day Notice |
| S018 |
2020-06-17 |
Real-time Process |
| S017 |
2020-05-13 |
Normal 180 Day Track No User Fee |
| S016 |
2019-10-08 |
Real-time Process |
| S015 |
2018-06-22 |
Normal 180 Day Track |
| S014 | | |
| S013 |
2018-03-23 |
30-day Notice |
| S012 |
2017-12-15 |
Normal 180 Day Track No User Fee |
| S011 |
2017-11-27 |
Normal 180 Day Track No User Fee |
| S010 |
2017-11-16 |
Normal 180 Day Track No User Fee |
| S009 |
2017-08-28 |
Normal 180 Day Track No User Fee |
| S008 |
2017-02-21 |
Normal 180 Day Track No User Fee |
| S007 |
2017-01-13 |
Normal 180 Day Track No User Fee |
| S006 |
2017-01-05 |
Normal 180 Day Track No User Fee |
| S005 |
2017-01-05 |
Normal 180 Day Track |
| S004 |
2016-07-25 |
Normal 180 Day Track |
| S003 |
2015-08-13 |
135 Review Track For 30-day Notice |
| S002 |
2015-06-22 |
Normal 180 Day Track No User Fee |
| S001 |
2015-06-22 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices