PMA P040001S015
- Device
- X-STOP INTERSPINOUS SPACER SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S015
- Product code
- NQO
- Decision date
- 2009-10-21
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- APPROVAL FOR CHANGES TO THE DEVICE NAME, INSTRUCTIONS FOR USE, AND PHYSICIAN¿S AND PATIENT¿S GUIDES.
Current openFDA PMA Record#
- Device
- X-STOP INTERSPINOUS SPACER SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S015
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2009-10-21
- Decision code
- APPR
- Date received
- 2009-09-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE DEVICE NAME, INSTRUCTIONS FOR USE, AND PHYSICIAN¿S AND PATIENT¿S GUIDES.