PMA P120024S008
- Device
- activeL Artificial Disc
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S008
- Product code
- MJO
- Decision date
- 2019-05-13
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for MR Conditional labeling for the activeL keel endplates.
Current openFDA PMA Record#
- Device
- activeL Artificial Disc
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S008
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2019-05-13
- Decision code
- APPR
- Date received
- 2019-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR Conditional labeling for the activeL keel endplates.