|
Device | CERAMAX CERAMIC TOTAL HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46582 |
PMA Number | P070026 |
Supplement Number | S029 |
Date Received | 03/03/2015 |
Decision Date | 03/25/2015 |
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 ADDING A MANUAL CHECK OF THE INLET RO WATER FLOW INTO TANK 7 TO ENSURE THAT ADDITIONAL ORDERS ARE NOT PROCESSED BY THE SYSTEM WHEN THE FLOW RATE IS BELOW THE 3 GALLON PER MINUTE REQUIREMENT. |