|
Device | CERAMIC TRANSCEND HIP ARTICULATION SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | CERAMTEC GMBH CERAMTEC-PLATZ 1-9 73207 PLOCHINGEN 73207 |
PMA Number | P010001 |
Supplement Number | S001 |
Date Received | 02/20/2003 |
Decision Date | 04/04/2003 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE LINEAGE ACETABULAR SHELL TO BE USED WITH THE TRANSCEND CERAMIC LINERS. |
Post-Approval Study | Show Report Schedule and Study Progress |