PMA P050010S010
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S010
- Product code
- MJO
- Decision date
- 2011-03-03
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A CHANGE FROM A MANUAL DEBURRING PROCESS TO AN AUTOMATED BRUSH DEBURRING PROCESS.
Current openFDA PMA Record#
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S010
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2011-03-03
- Decision code
- APPR
- Date received
- 2010-09-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE FROM A MANUAL DEBURRING PROCESS TO AN AUTOMATED BRUSH DEBURRING PROCESS.