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. |
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Device | CERAMIC TRANSCEND HIP ARTICULATION SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | CERAMTEC GMBH CERAMTEC-PLATZ 1-9 73207 PLOCHINGEN 73207 |
PMA Number | P010001 |
Supplement Number | S022 |
Date Received | 12/23/2019 |
Decision Date | 01/22/2020 |
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 Firm requests to change the corrosion protection oil for the proof-test machine. |
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