This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P190006S053 |
| Classification Name | None |
| Applicant | |
| PMA | P190006 |
| Supplement | S053 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190006 | Original Filing | |
| S064 | 2023-01-10 | 30-day Notice |
| S063 | ||
| S062 | 2022-09-29 | Normal 180 Day Track |
| S061 | 2022-09-19 | Normal 180 Day Track |
| S060 | 2022-08-15 | 30-day Notice |
| S059 | 2022-08-11 | 30-day Notice |
| S058 | ||
| S057 | 2022-06-30 | 30-day Notice |
| S056 | ||
| S055 | 2022-04-15 | 30-day Notice |
| S054 | ||
| S053 | ||
| S052 | 2022-03-24 | 30-day Notice |
| S051 | 2022-02-07 | 30-day Notice |
| S050 | 2022-01-14 | 30-day Notice |
| S049 | 2022-01-05 | 30-day Notice |
| S048 | ||
| S047 | 2021-12-15 | 30-day Notice |
| S046 | ||
| S045 | 2021-12-07 | 30-day Notice |
| S044 | ||
| S043 | 2021-10-27 | 30-day Notice |
| S042 | 2021-10-18 | 30-day Notice |
| S041 | ||
| S040 | ||
| S039 | ||
| S038 | ||
| S037 | 2021-04-26 | 30-day Notice |
| S036 | ||
| S035 | ||
| S034 | 2021-02-25 | 30-day Notice |
| S033 | 2021-02-16 | 30-day Notice |
| S032 | 2021-02-08 | 30-day Notice |
| S031 | 2021-02-01 | 30-day Notice |
| S030 | 2021-02-01 | 30-day Notice |
| S029 | 2021-01-25 | 30-day Notice |
| S028 | ||
| S027 | ||
| S026 | 2020-11-05 | Real-time Process |
| S025 | ||
| S024 | ||
| S023 | 2020-10-06 | 30-day Notice |
| S022 | 2020-10-02 | 30-day Notice |
| S021 | 2020-08-24 | 30-day Notice |
| S020 | ||
| S019 | 2020-07-02 | 30-day Notice |
| S018 | 2020-06-16 | 30-day Notice |
| S017 | 2020-06-12 | 30-day Notice |
| S016 | 2020-06-05 | 30-day Notice |
| S015 | ||
| S014 | ||
| S013 | ||
| S012 | ||
| S011 | 2020-04-02 | Normal 180 Day Track |
| S010 | 2020-03-16 | 30-day Notice |
| S009 | 2020-03-11 | 30-day Notice |
| S008 | 2020-03-06 | 30-day Notice |
| S007 | 2020-03-06 | 30-day Notice |
| S006 | ||
| S005 | 2020-01-31 | 30-day Notice |
| S004 | ||
| S003 | 2019-12-30 | 30-day Notice |
| S002 | 2019-10-18 | Real-time Process |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 10810005340387 | P190006 | 000 |
| 10810005340158 | P190006 | 000 |
| 10810005340141 | P190006 | 000 |
| 10810005340134 | P190006 | 000 |
| 10810005340127 | P190006 | 000 |
| 10810005340103 | P190006 | 000 |
| 10810005340080 | P190006 | 000 |
| 10810005340066 | P190006 | 000 |
| 10810005340059 | P190006 | 000 |
| 10810005340035 | P190006 | 000 |
| 10810005340028 | P190006 | 000 |
| 10810005340189 | P190006 | 000 |
| 10810005340196 | P190006 | 000 |
| 10810005340219 | P190006 | 000 |
| 10810005340370 | P190006 | 000 |
| 10810005340325 | P190006 | 000 |
| 10810005340301 | P190006 | 000 |
| 10810005340288 | P190006 | 000 |
| 10810005340271 | P190006 | 000 |
| 10810005340264 | P190006 | 000 |
| 10810005340257 | P190006 | 000 |
| 10810005340240 | P190006 | 000 |
| 10810005340233 | P190006 | 000 |
| 10810005340226 | P190006 | 000 |
| 10810005340011 | P190006 | 000 |