PMA P000035S006

Device: TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
Applicant: Nexus CMF, LLC
PMA number: P000035
Supplement: S006
Product code: MPI
Decision date: 2012-01-31
Generic name: Glenoid fossa prosthesis
Approval order statement: APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.

Current openFDA PMA Record#

Device: TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
Applicant: Nexus CMF, LLC
PMA number: P000035
Supplement: S006
Product code: MPI
Generic name: Glenoid fossa prosthesis
Decision date: 2012-01-31
Decision code: APPR
Date received: 2011-05-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.