|
Trade Name | ASCENSION PIP |
Classification Name | finger semi-constrained pyrolytic carbon uncemented prosthesis |
Generic Name | finger semi-constrained pyrolytic carbon uncemented prosthesis |
Applicant |
Smith & Nephew, Inc. |
7135 goodlett farms parkway |
cordova, TN 38016 |
|
HDE Number | H010005 |
Supplement Number | S001 |
Date Received | 11/13/2002 |
Decision Date | 01/28/2003 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This supplement was to update labeling to contain current adverse event and complications rates. |