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 | FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM |
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 | S002 |
Date Received | 06/20/2002 |
Decision Date | 09/12/2002 |
Product Code |
MPI |
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 "CRYSTAL CLEAR ANATOMICAL MODEL PACKAGE INSERT." |
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