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 | S004 |
Date Received | 12/02/2009 |
Decision Date | 01/29/2010 |
Product Code |
LZD |
Advisory Committee |
Dental |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE PACKAGING MATERIALS OF BOTH THE FOSSA AND THE MANDIBULAR TMJ SYSTEM COMPONENTS, AND EXTENSION OF THE SHELF LIFE OF THESE DEVICES TO 5 YEARS. |
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