PMA P060018S001
- Device
- PRESTIGE CERVICAL DISC
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P060018
- Supplement
- S001
- Product code
- MJO
- Decision date
- 2007-09-18
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL (I.E., MODIFICATION OF FIGURE 8 AND THE ADDITION OF A CAUTIONARY NOTE).
Current openFDA PMA Record#
- Device
- PRESTIGE CERVICAL DISC
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P060018
- Supplement
- S001
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2007-09-18
- Decision code
- APPR
- Date received
- 2007-09-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL (I.E., MODIFICATION OF FIGURE 8 AND THE ADDITION OF A CAUTIONARY NOTE).