|
Device | ASCENSION ORTHOPEDICS MCP |
Generic Name | Finger semi-constrained pyrolytic carbon uncemented prosthesis |
Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
PMA Number | P000057 |
Supplement Number | S004 |
Date Received | 02/19/2008 |
Decision Date | 04/24/2008 |
Product Code |
NEG |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A HYDROXYAPATITE (HA) COATING TO TE STEM OF THE ASCENSION MCP PROXIMAL AND DISTAL COMPONENTS. |