FDA.reportPublic FDA data

PMA P150030S047

Device
R3™ Delta Ceramic Acetabular System
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S047
Product code
MRA
Decision date
2025-02-21
Classification
Orthopedic
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
to introduce an additional production aid for the coating of the cleaning basket used in the in-process cleaning, fine cleaning, and final rinsing process steps for POLARSTEM.

Current openFDA PMA Record#

Device
R3™ Delta Ceramic Acetabular System
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S047
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2025-02-21
Decision code
OK30
Date received
2025-01-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to introduce an additional production aid for the coating of the cleaning basket used in the in-process cleaning, fine cleaning, and final rinsing process steps for POLARSTEM.