|
Device | DURALOC OPTION CERAMIC HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P040023 |
Supplement Number | S024 |
Date Received | 08/03/2012 |
Decision Date | 09/06/2012 |
Withdrawal Date
|
04/03/2014 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING. |