PMA P000035S010

Device
TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM
Applicant
Nexus CMF, LLC
PMA number
P000035
Supplement
S010
Product code
MPI
Decision date
2014-05-21
Generic name
Glenoid fossa prosthesis
Approval order statement
ADD WATER QUALITY STANDARDS.

Current openFDA PMA Record#

Device
TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM
Applicant
Nexus CMF, LLC
PMA number
P000035
Supplement
S010
Product code
MPI
Generic name
Glenoid fossa prosthesis
Decision date
2014-05-21
Decision code
OK30
Date received
2014-05-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADD WATER QUALITY STANDARDS.