|
Device | R3 Delta Ceramic Hip System |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P150030 |
Supplement Number | S037 |
Date Received | 10/31/2023 |
Decision Date | 01/19/2024 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT03056534
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150030 |