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. |
|
Device | TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st |
Generic Name | Joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant | TMJ CONCEPTS 2233 KNOLL DRIVE VENTURA, CA 93003 |
PMA Number | P980052 |
Supplement Number | S012 |
Date Received | 08/04/2023 |
Decision Date | 08/22/2023 |
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 Implementation of SAP ERP System to replace Factory Edge |
|
|