FDA.reportPublic FDA data

PMA P150030S010

Device
R3 Delta Ceramic Acetabular System
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S010
Product code
MRA
Decision date
2021-06-30
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Tecomet, one of the current forging blanks suppliers, has added a new extrusion press for the forging process of POLARSTEM Stems during early production.

Current openFDA PMA Record#

Device
R3 Delta Ceramic Acetabular System
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S010
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2021-06-30
Decision code
OK30
Date received
2021-06-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Tecomet, one of the current forging blanks suppliers, has added a new extrusion press for the forging process of POLARSTEM Stems during early production.