PMA P100003
- Device
- SECURE®-C Cervical Artificial Disc
- Applicant
- Globus Medical, Inc.
- PMA number
- P100003
- Supplement
- S007
- Product code
- MJO
- Decision date
- 2023-06-12
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval to update labeling for the SECURE®-C to reflect the findings of the Enhanced Surveillance Study (PAS2).
Current openFDA PMA Record#
- Device
- SECURE®-C Cervical Artificial Disc
- Applicant
- Globus Medical, Inc.
- PMA number
- P100003
- Supplement
- S008
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2023-06-12
- Decision code
- APPR
- Date received
- 2023-02-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval to update labeling for the SECURE®-C to reflect the findings of the Enhanced Surveillance Study (PAS2).