|
Device | 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 | S010 |
Date Received | 06/10/2011 |
Decision Date | 02/14/2012 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ALTERNATE POLISHING MACHINE AT THE PLOCHINGEN, GERMANY FACILITY. |