Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceTotal Temporomandibular Joint Replacement System
ApplicantBiomet Microfixation, Inc.
1520 Tradeport Dr.
Jacksonville, FL 32218
PMA NumberP020016
Supplement NumberS010
Date Received10/18/2018
Decision Date07/27/2026
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.
-
-