PMA P190030S003

Device: ActaStim-S Spine Fusion Stimulator
Applicant: Theragen, Inc.
PMA number: P190030
Supplement: S003
Product code: LOF
Decision date: 2024-11-13
Classification: Orthopedic
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for minor changes to the device’s Instructions for Use to indicate that the device provides 270 days of continuous treatment, to revise the instructions to the user upon completion of treatment, and to indicate that the ActaStim-S system, excluding consumables, has an expected lifetime of three years.

Current openFDA PMA Record#

Device: ActaStim-S Spine Fusion Stimulator
Applicant: Theragen, Inc.
PMA number: P190030
Supplement: S003
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2024-11-13
Decision code: APPR
Date received: 2024-08-15
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for minor changes to the device’s Instructions for Use to indicate that the device provides 270 days of continuous treatment, to revise the instructions to the user upon completion of treatment, and to indicate that the ActaStim-S system, excluding consumables, has an expected lifetime of three years.