- Device
- prodisc C Total Disc Replacement
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S018
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2020-05-08
- Decision code
- APPR
- Date received
- 2019-06-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional cleaning, passivation and thermal rinse steps, and the following four (4) manufacturing sites, at the following addresses, and for the following purposes:Centinel Spine (Manufacturer)900 Airport Road Suite 3BWest Chester, PA 19380Hammill Medical (Contract Manufacturer)360 Tomahawk DriveMaumee, OH 43537Fruh Verpackungstechnik AG (Contract Manufacturer)Allmendstrasse 47Fehraltoff Switzerland 8320Synergy Health Daniken AG (Contract Sterilizer)Hogenweidstrasse 6Daniken Solothurn Switzerland 4658