PMA P040001S020
- Device
- X-STOP INTERSPINOUS SPACER SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S020
- Product code
- NQO
- Decision date
- 2012-07-25
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC. IN MEMPHIS, TENNESSEE.
Current openFDA PMA Record#
- Device
- X-STOP INTERSPINOUS SPACER SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S020
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2012-07-25
- Decision code
- APPR
- Date received
- 2012-02-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC. IN MEMPHIS, TENNESSEE.