|
Device | 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 | S004 |
Date Received | 03/03/2009 |
Decision Date | 09/02/2009 |
Product Code |
LZD |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFIED LABELING. |