PMA P030022S028

Device
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S028
Product code
MRA
Decision date
2014-01-13
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
CHANGE TO A DIFFERENT DETERGENT CHELATING AGENT.

Current openFDA PMA Record#

Device
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
Applicant
Smith & Nephew, Inc.
PMA number
P030022
Supplement
S028
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2014-01-13
Decision code
OK30
Date received
2013-12-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO A DIFFERENT DETERGENT CHELATING AGENT.