PMA P100012
- Device
- NuVasive PCM Cervical Disc
- Applicant
- Nuvasive, Inc.
- PMA number
- P100012
- Supplement
- S008
- Product code
- MJO
- Decision date
- 2019-04-03
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for labeling updated to include post-approval study results.
Current openFDA PMA Record#
- Device
- NuVasive PCM Cervical Disc
- Applicant
- Nuvasive, Inc.
- PMA number
- P100012
- Supplement
- S008
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2019-04-03
- Decision code
- APPR
- Date received
- 2018-05-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling updated to include post-approval study results.