Approval for a manufacturing site located at synergey health daniken ag (a. K. A steris), daniken so, solothurn, 4658 switzerland (establishment registration number 3002808269) as an alternative vendor for gamma sterilization of the r3tm us delta ceramic liner and r3tm us delta ceramic heads, approved under p150030
| Device | R3 DELTA CERAMIC HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Smith & Nephew, Inc. |
| Date Received | 2021-11-08 |
| Decision Date | 2021-12-08 |
| PMA | P150030 |
| Supplement | S017 |
| Product Code | MRA |
| 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 | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150030 | | Original Filing |
| S028 |
2022-10-25 |
30-day Notice |
| S027 |
2022-08-31 |
30-day Notice |
| S026 |
2022-08-23 |
30-day Notice |
| S025 |
2022-08-16 |
30-day Notice |
| S024 |
2022-08-05 |
30-day Notice |
| S023 |
2022-07-14 |
30-day Notice |
| S022 |
2022-05-23 |
30-day Notice |
| S021 |
2022-04-29 |
30-day Notice |
| S020 |
2022-04-06 |
30-day Notice |
| S019 |
2022-03-07 |
30-day Notice |
| S018 |
2021-11-22 |
30-day Notice |
| S017 |
2021-11-08 |
Normal 180 Day Track No User Fee |
| S016 | | |
| S015 |
2021-10-13 |
30-day Notice |
| S014 | | |
| S013 | | |
| S012 | | |
| S011 |
2021-06-07 |
30-day Notice |
| S010 |
2021-06-04 |
30-day Notice |
| S009 |
2021-06-04 |
30-day Notice |
| S008 |
2020-07-22 |
Normal 180 Day Track No User Fee |
| S007 |
2019-05-09 |
30-day Notice |
| S006 |
2018-11-21 |
Real-time Process |
| S005 |
2018-08-22 |
Normal 180 Day Track No User Fee |
| S004 |
2017-11-24 |
30-day Notice |
| S003 |
2017-08-17 |
Normal 180 Day Track No User Fee |
| S002 |
2017-05-04 |
30-day Notice |
| S001 |
2016-11-07 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices