|
Device | Patient-Fitted TMJ Reconstruction Prosthesis System |
Generic Name | Joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | TMJ CONCEPTS 2233 KNOLL DRIVE VENTURA, CA 93003 |
PMA Number | P980052 |
Supplement Number | S008 |
Date Received | 10/27/2020 |
Decision Date | 11/24/2020 |
Product Code |
LZD |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to implement new sterilization equipment for the same approved sterilization type and cycle. |