|
Device | CERAMTEC 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 | S004 |
Date Received | 07/18/2007 |
Decision Date | 08/17/2007 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF NEW SOFTWARE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF TWO INNER SPHERE POLISHING STATIONS. |
Post-Approval Study | Show Report Schedule and Study Progress |