PMA P050010S011
- Device
- PRODISC - L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S011
- Product code
- MJO
- Decision date
- 2011-09-16
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A CHANGE TO A NEW CALIBRATION SOFTWARE PROGRAM.
Current openFDA PMA Record#
- Device
- PRODISC - L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S011
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2011-09-16
- Decision code
- APPR
- Date received
- 2011-01-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO A NEW CALIBRATION SOFTWARE PROGRAM.