PMA P070001S004
- Device
- PRODISC-C TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S004
- Product code
- MJO
- Decision date
- 2011-01-14
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN WEST CHESTER, PENNSYLVANIA.
Current openFDA PMA Record#
- Device
- PRODISC-C TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S004
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2011-01-14
- Decision code
- APPR
- Date received
- 2010-05-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN WEST CHESTER, PENNSYLVANIA.