• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
Classification Nameglenoid fossa prosthesis
Regulation Number872.3950
ApplicantTMJ MEDICAL
PMA NumberP000035
Supplement NumberS008
Date Received05/04/2012
Decision Date09/06/2012
Product Code
MPI
Advisory Committee Dental
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment.
-
-