|
Device | TRILOGY AB ACETABULAR SYSTEM PACKAGE INSERT |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | ZIMMER, INC. P.O. Box 708 Warsaw, IN 46581-0708 |
PMA Number | P040048 |
Supplement Number | S014 |
Date Received | 05/02/2011 |
Decision Date | 06/02/2011 |
Withdrawal Date
|
08/29/2012 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING INFORMATION ABOUT MRI SAFETY TO THE PACKAGE INSERT AND PATIENT LABELING. |