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 NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-16 |
| Decision Date | 2022-09-13 |
| PMA | P150030 |
| Supplement | S025 |
| 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 NumberS025 Date Received08/16/2022 Decision Date09/13/2022 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 the Introduction Of The Newest Version Of The ZEISS Microscope Used To Verify The Vacuum Plasma Spray (VPS) Coating Process Step |
| 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 |