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 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 | S005 |
Date Received | 05/18/2010 |
Decision Date | 11/08/2010 |
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 STUDY FOR THE WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM. |
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