|
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 | S008 |
Date Received | 09/18/2015 |
Decision Date | 11/25/2015 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a revision to your surgical technique, as outlined in appendix a of the supplement. |