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 | CERAMAX CERAMIC 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 | S043 |
Date Received | 10/31/2016 |
Decision Date | 11/28/2016 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Special Supplement |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized. |
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