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 | NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 |
PMA Number | P050039 |
Supplement Number | S018 |
Date Received | 12/09/2015 |
Decision Date | 12/30/2015 |
Withdrawal Date
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12/31/2020 |
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 ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS. |
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