PMA P040001S003
- Device
- X-STOP IPD SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S003
- Product code
- NQO
- Decision date
- 2006-10-19
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- CHANGES IN PACKAGING FOOTPRINT, PACKAGING PROCESSES, LABELING PROCESSES AND MANUFACTURING FLOW FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- X-STOP IPD SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- PMA number
- P040001
- Supplement
- S003
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2006-10-19
- Decision code
- OK30
- Date received
- 2006-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN PACKAGING FOOTPRINT, PACKAGING PROCESSES, LABELING PROCESSES AND MANUFACTURING FLOW FOR THE DEVICE.