PMA P060018S002
- Device
- PRESTIGE CERVICAL DISC
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P060018
- Supplement
- S002
- Product code
- MJO
- Decision date
- 2011-03-24
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR A CHANGE OF LOCATION OF THE ORCHID ANZON (FORMERLY ANZON COMPANY, INC.) FACILITY.
Current openFDA PMA Record#
- Device
- PRESTIGE CERVICAL DISC
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P060018
- Supplement
- S002
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2011-03-24
- Decision code
- APPR
- Date received
- 2010-10-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE OF LOCATION OF THE ORCHID ANZON (FORMERLY ANZON COMPANY, INC.) FACILITY.