|
Device | CERAMIC TRANSCEND ARTICULATION SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | MicroPort Orthopedics Inc. 5677 AIRLINE RD ARLINGTON, TN 38002-0000 |
PMA Number | P030027 |
Supplement Number | S007 |
Date Received | 04/26/2013 |
Decision Date | 01/03/2014 |
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 CHANGING THE INCOMING INSPECTION PROCESS OFCOMPONENTS FROM THE SUPPLIER. |