Saluda Medical Evoke SCS System
FDA premarket approval P190002 · decided 2022-02-28
Approval details
- PMA number
- P190002
- Trade name
- Saluda Medical Evoke SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2019-01-22
- Decision date
- 2022-02-28
- Days to decision
- 1133 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for the Evoke® SCS System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbsincluding unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
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