PMA P000035S004
- Device
- TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
- Applicant
- Nexus CMF, LLC
- PMA number
- P000035
- Supplement
- S004
- Product code
- MPI
- Decision date
- 2003-10-14
- Generic name
- Glenoid fossa prosthesis
- Approval order statement
- APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.
Current openFDA PMA Record#
- Device
- TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
- Applicant
- Nexus CMF, LLC
- PMA number
- P000035
- Supplement
- S004
- Product code
- MPI
- Generic name
- Glenoid fossa prosthesis
- Decision date
- 2003-10-14
- Decision code
- APPR
- Date received
- 2002-12-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.