PMA P070001

Device: prodisc® C Nova
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S021
Product code: MJO
Decision date: 2026-09-09
Generic name: Prosthesis, intervertebral disc
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for the prodisc® C Nova requesting expansion of the indications from one-level use to two-level use.

Current openFDA PMA Record#

Device: prodisc® C Nova
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S031
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-09-09
Decision code: APPR
Date received: 2026-05-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for the prodisc® C Nova requesting expansion of the indications from one-level use to two-level use.