PMA P120024S003
- Device
- ACTIVL ARTIFICIAL DISC
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S003
- Product code
- MJO
- Decision date
- 2015-12-17
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGES TO THE REPORTING TIMELINE AND ACTIVL® SURGEON SURVEY.
Current openFDA PMA Record#
- Device
- ACTIVL ARTIFICIAL DISC
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S003
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2015-12-17
- Decision code
- APPR
- Date received
- 2015-11-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGES TO THE REPORTING TIMELINE AND ACTIVL® SURGEON SURVEY.