PMA P050010S017
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S017
- Product code
- MJO
- Decision date
- 2016-02-04
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Change in sterile package sealing pressure parameter (from 60 psi to 90 psi).
Current openFDA PMA Record#
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S017
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2016-02-04
- Decision code
- OK30
- Date received
- 2016-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in sterile package sealing pressure parameter (from 60 psi to 90 psi).