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 | 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 | S103 |
Date Received | 11/28/2022 |
Decision Date | 12/08/2022 |
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 Changing the frequency of the chemistry test from each furnace cycle to bi-weekly and consequential procedural update. |
|
|