ActaStim-S Spine Fusion Stimulator
FDA premarket approval P190030 · decided 2020-12-09
Approval details
- PMA number
- P190030
- Trade name
- ActaStim-S Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Theragen, Inc.
- Date received
- 2019-11-18
- Decision date
- 2020-12-09
- Days to decision
- 387 days
- Decision code
- APRL
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Manassas, VA
- Statement
- Approval for the ActaStim-S Spine Fusion Stimulator is a noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is Rx only, and intended for single patient use in adult patients only.
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