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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantTMJ IMPLANTS, INC.
PMA NumberP000023
Supplement NumberS001
Date Received06/18/2002
Decision Date09/12/2002
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the "surgeon's manual. ".
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