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 | Vertiflex Instrument Platform (VIP) Kit |
| Generic Name | Prosthesis, Spinous Process Spacer/plate |
| Applicant | Boston Scientific Neuromodulation25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP140004 Supplement NumberS028 Date Received12/03/2021 Decision Date03/02/2022 Product Code NQO Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2021-12-03 |
| Decision Date | 2022-03-02 |
| PMA | P140004 |
| Supplement | S028 |
| Product Code | NQO |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Neuromodulation 25155 Rye Canyon Loop valencia, CA 91355 PMA NumberP140004 Supplement NumberS028 Date Received12/03/2021 Decision Date03/02/2022 Product Code NQO Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A Manufacturing Change For An Instrument Component. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00884662000529 | P140004 | 004 |