PMA P000057S006

Device
ASCENSION ORTHOPEDICS MCP
Applicant
Smith & Nephew, Inc.
PMA number
P000057
Supplement
S006
Product code
NEG
Decision date
2011-08-26
Classification
Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis
Generic name
Finger semi-constrained pyrolytic carbon uncemented prosthesis
Approval order statement
APPROVAL FOR A CHANGE TO THE COATING SUPPLIER MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device
ASCENSION ORTHOPEDICS MCP
Applicant
Smith & Nephew, Inc.
PMA number
P000057
Supplement
S006
Product code
NEG
Generic name
Finger semi-constrained pyrolytic carbon uncemented prosthesis
Decision date
2011-08-26
Decision code
APPR
Date received
2010-04-07
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A CHANGE TO THE COATING SUPPLIER MANUFACTURING FACILITY.