PMA P020016S007
- Device
- TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S007
- Product code
- LZD
- Decision date
- 2014-12-09
- Generic name
- Joint, temporomandibular, implant
- Approval order statement
- ELIMINATE A STEP WITHIN THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- Applicant
- Biomet Microfixation, Inc.
- PMA number
- P020016
- Supplement
- S007
- Product code
- LZD
- Generic name
- Joint, temporomandibular, implant
- Decision date
- 2014-12-09
- Decision code
- OK30
- Date received
- 2014-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATE A STEP WITHIN THE MANUFACTURING PROCESS.