Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 | S008 |
Date Received | 12/10/2015 |
Decision Date | 12/30/2015 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS. |
|
|