SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim
FDA premarket approval P150004/S074 · decided 2025-03-12
Approval details
- PMA number
- P150004
- Supplement
- S074
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-04-26
- Decision date
- 2025-03-12
- Days to decision
- 320 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- This premarket approval application (PMA) 180-day supplement requested approval for design changes to the DRG sheaths used in the DRG Lead Kits and Sheath Accessory Kits
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