PMA P100012S002
- Device
- PCM CERVICAL DISC
- Applicant
- Nuvasive, Inc.
- PMA number
- P100012
- Supplement
- S002
- Product code
- MJO
- Decision date
- 2013-03-29
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PATIENT BROCHURE.
Current openFDA PMA Record#
- Device
- PCM CERVICAL DISC
- Applicant
- Nuvasive, Inc.
- PMA number
- P100012
- Supplement
- S002
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2013-03-29
- Decision code
- APPR
- Date received
- 2013-01-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PATIENT BROCHURE.