Change to conveyor system used during gamma irradiation terminal sterilization.
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 | 2021-11-22 |
Decision Date | 2021-12-20 |
PMA | P150030 |
Supplement | S018 |
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 |
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