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 | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM |
Generic Name | Joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | TMJ CONCEPTS 2233 KNOLL DRIVE VENTURA, CA 93003 |
PMA Number | P980052 |
Supplement Number | S002 |
Date Received | 11/27/2002 |
Decision Date | 01/14/2003 |
Product Code |
LZD |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA. |
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