PMA P040001S007
- Device
- X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S007
- Product code
- NQO
- Decision date
- 2007-10-04
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- APPROVAL FOR A MODIFIED VERSION OF THE TISSUE EXPANDER OF THE TITANIUM VERSION OF THE X-STOP SPACER ASSEMBLY.
Current openFDA PMA Record#
- Device
- X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S007
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2007-10-04
- Decision code
- APPR
- Date received
- 2007-06-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFIED VERSION OF THE TISSUE EXPANDER OF THE TITANIUM VERSION OF THE X-STOP SPACER ASSEMBLY.