FDA.reportPublic FDA data

PMA P150030S017

Device
R3 DELTA CERAMIC HIP SYSTEM
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S017
Product code
MRA
Decision date
2021-12-08
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
Approval for a manufacturing site located at Synergey Health Daniken AG (a.k.a STERIS), Daniken So, Solothurn, 4658 Switzerland as an alternative vendor for gamma sterilization of the R3TM US Delta Ceramic Liner and R3TM US Delta Ceramic Heads.

Current openFDA PMA Record#

Device
R3 DELTA CERAMIC HIP SYSTEM
Applicant
Smith & Nephew, Inc.
PMA number
P150030
Supplement
S017
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2021-12-08
Decision code
APPR
Date received
2021-11-08
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Synergey Health Daniken AG (a.k.a STERIS), Daniken So, Solothurn, 4658 Switzerland as an alternative vendor for gamma sterilization of the R3TM US Delta Ceramic Liner and R3TM US Delta Ceramic Heads.