PMA P190030S002
- Device
- ActaStim-S Non Invasive Spine Fusion Stimulator
- Applicant
- Theragen, Inc.
- PMA number
- P190030
- Supplement
- S002
- Product code
- LOF
- Decision date
- 2023-03-23
- Classification
- Orthopedic
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Distribute the device incorporating the alternative battery.
Current openFDA PMA Record#
- Device
- ActaStim-S Non Invasive Spine Fusion Stimulator
- Applicant
- Theragen, Inc.
- PMA number
- P190030
- Supplement
- S002
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2023-03-23
- Decision code
- OK30
- Date received
- 2023-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Distribute the device incorporating the alternative battery.