|
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 | S015 |
Date Received | 12/02/2009 |
Decision Date | 06/04/2010 |
Withdrawal Date
|
04/03/2014 |
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 A MANUFACTURING PROCESS CHANGE TO THE GRIT BLAST OPERATION FOR THE POROUS COATED SUMMIT HIP FEMORAL PROSTHESIS. |