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 | CORMET HIP RESURFACING SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
Applicant | CORIN U.S.A. 12750 Citrus Park Lane Suite 120 Tampa, FL 33607 |
PMA Number | P050016 |
Supplement Number | S011 |
Date Received | 07/06/2016 |
Decision Date | 12/21/2016 |
Product Code |
NXT |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to the device labeling (i.e., package insert, surgical technique, and patient labeling) to include a summary of the results of the completed post-approval study (PAS). |
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