PMA P000057S004

Device
ASCENSION ORTHOPEDICS MCP
Applicant
Smith & Nephew, Inc.
PMA number
P000057
Supplement
S004
Product code
NEG
Decision date
2008-04-24
Classification
Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis
Generic name
Finger semi-constrained pyrolytic carbon uncemented prosthesis
Approval order statement
APPROVAL TO ADD A HYDROXYAPATITE (HA) COATING TO TE STEM OF THE ASCENSION MCP PROXIMAL AND DISTAL COMPONENTS.

Current openFDA PMA Record#

Device
ASCENSION ORTHOPEDICS MCP
Applicant
Smith & Nephew, Inc.
PMA number
P000057
Supplement
S004
Product code
NEG
Generic name
Finger semi-constrained pyrolytic carbon uncemented prosthesis
Decision date
2008-04-24
Decision code
APPR
Date received
2008-02-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL TO ADD A HYDROXYAPATITE (HA) COATING TO TE STEM OF THE ASCENSION MCP PROXIMAL AND DISTAL COMPONENTS.