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 | R3™ Delta Ceramic Acetabular System |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS020 Date Received04/06/2022 Decision Date05/03/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-06 |
| Decision Date | 2022-05-03 |
| PMA | P150030 |
| Supplement | S020 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway cordova, TN 38016 PMA NumberP150030 Supplement NumberS020 Date Received04/06/2022 Decision Date05/03/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of An Established Packaging Site As A Second Source For Performing The Packaging Processes Of The POLARSTEM Stems. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00885556499290 | P150030 | 000 |
| 00885556498590 | P150030 | 000 |
| 00885556498644 | P150030 | 000 |
| 00885556498699 | P150030 | 000 |
| 00885556498743 | P150030 | 000 |
| 00885556498798 | P150030 | 000 |
| 00885556498842 | P150030 | 000 |
| 00885556498897 | P150030 | 000 |
| 00885556498941 | P150030 | 000 |
| 00885556498996 | P150030 | 000 |
| 00885556499047 | P150030 | 000 |
| 00885556499092 | P150030 | 000 |
| 00885556499146 | P150030 | 000 |
| 00885556499191 | P150030 | 000 |
| 00885556499245 | P150030 | 000 |
| 00885556498545 | P150030 | 000 |