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PMA P150030S011

Device
R3 Delta Ceramic Acetabular System
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S011
Product code
MRA
Decision date
2021-06-29
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Addition of manufacturing equipment used in the raw material forging of the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA, which are approved for use in combination with the R3 Delta Ceramic Acetabular System.

Current openFDA PMA Record#

Device
R3 Delta Ceramic Acetabular System
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S011
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2021-06-29
Decision code
OK30
Date received
2021-06-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of manufacturing equipment used in the raw material forging of the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA, which are approved for use in combination with the R3 Delta Ceramic Acetabular System.