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 | TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM |
Generic Name | joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | BIOMET MICROFIXATION, INC. 1520 tradeport dr. jacksonville, FL 32218 |
PMA Number | P020016 |
Supplement Number | S008 |
Date Received | 12/14/2016 |
Decision Date | 06/08/2017 |
Product Code |
LZD |
Advisory Committee |
Dental |
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 PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM. |
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