PMA P040001S022
- Device
- X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S022
- Product code
- NQO
- Decision date
- 2014-10-24
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S022
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2014-10-24
- Decision code
- APPR
- Date received
- 2014-08-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.