PMA P050010S006
- Device
- PRODISC L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S006
- Product code
- MJO
- Decision date
- 2010-05-26
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- UPGRADE OF THE ROFIN BAASEL SOFTWARE, WHICH CONTROLS THE ETCHING MACHINE, FROM VERSION 1.0.54 TO 1.0.61.
Current openFDA PMA Record#
- Device
- PRODISC L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S006
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2010-05-26
- Decision code
- OK30
- Date received
- 2010-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPGRADE OF THE ROFIN BAASEL SOFTWARE, WHICH CONTROLS THE ETCHING MACHINE, FROM VERSION 1.0.54 TO 1.0.61.