|
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 | S005 |
Date Received | 09/02/2010 |
Decision Date | 04/20/2011 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the supplier manufacturing facility of on-x life technology. |