Saluda Medical Evoke® SCS System
FDA premarket approval P190002/S014 · decided 2023-09-22
Approval details
- PMA number
- P190002
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Saluda Medical Evoke® SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2022-09-30
- Decision date
- 2023-09-22
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for a labeling change to the following implantable components of the Saluda Evoke Spinal Cord Stimulation (SCS) System as Magnetic Resonance (MR) Conditional for head and extremities (1.5 or 3.0 T) and full body (1.5 T):1) Evoke Closed Loop Stimulator Kit;2) Evoke CAP12 Percutaneous Leads Kit 60/90cm;3) Evoke 12C Percutaneous Leads Kit 60/90cm;4) Evoke Spares Kit;5) Evoke Active Anchor Kit; and6) Evoke CAP12X Lead Extension Kit 55cm.
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