Alternative Active Anchor (part number 104504)
FDA premarket approval P190002/S027 · decided 2024-05-16
Approval details
- PMA number
- P190002
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Alternative Active Anchor (part number 104504)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2024-02-16
- Decision date
- 2024-05-16
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for the alternative active anchor (part number 104504) which includes the following modifications 1) the curvature of the clamping surface of the bottom clamp plate changed from 0.9mm to 0.66m, and a 0.4mm chamfer was added to the lead edge to facilitate lead insertion, 2) the curved clamping surface of the top clamp plate was removed so that the clamping surface is flat, and 3) the silicone sleeve was removed from within the clamping surfaces.
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