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 FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS |
Generic Name | glenoid fossa prosthesis |
Regulation Number | 872.3950 |
Applicant | NEXUS CMF, LLC 17301 west colfax avenue suite 170 golden, CO 80401 |
PMA Number | P000035 |
Supplement Number | S004 |
Date Received | 12/26/2002 |
Decision Date | 10/14/2003 |
Product Code |
MPI |
Advisory Committee |
Dental |
Supplement Type | normal 180 day track |
Supplement Reason | other report |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS. |
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