PMA P120024S005
- Device
- Aesculap Implant Systems
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S005
- Product code
- MJO
- Decision date
- 2017-04-26
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval of changes to the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Aesculap Implant Systems
- Applicant
- Highridge Medical, LLC
- PMA number
- P120024
- Supplement
- S005
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2017-04-26
- Decision code
- APPR
- Date received
- 2017-02-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of changes to the protocol for the post-approval study (PAS) protocol.