Altius® Direct Electrical Nerve Stimulation System
FDA premarket approval P230020 · decided 2024-08-26
Approval details
- PMA number
- P230020
- Trade name
- Altius® Direct Electrical Nerve Stimulation System
- Generic name
- stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
- Applicant
- Neuros Medical, Inc.
- Date received
- 2023-06-30
- Decision date
- 2024-08-26
- Days to decision
- 423 days
- Decision code
- APPR
- Product code
- SAZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval order for Altius® Direct Electrical Nerve Stimulation System. This device is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees.
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