PMA P050010S012
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S012
- Product code
- MJO
- Decision date
- 2012-07-10
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL OF A PROTOCOL FOR EXTENSION OF SHELF-LIFE FOR THE POLYETHYLENE INLAY COMPONENT FROM THREE (3) YEARS TO FIVE (5) YEARS.
Current openFDA PMA Record#
- Device
- PRODISC-L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S012
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2012-07-10
- Decision code
- APPR
- Date received
- 2011-04-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL OF A PROTOCOL FOR EXTENSION OF SHELF-LIFE FOR THE POLYETHYLENE INLAY COMPONENT FROM THREE (3) YEARS TO FIVE (5) YEARS.