DRG Neurostimulation System
FDA premarket approval P150004/S091 · decided 2025-09-25
Approval details
- PMA number
- P150004
- Supplement
- S091
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DRG Neurostimulation System
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-08-27
- Decision date
- 2025-09-25
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- the following changes for the shaft of the torque wrench accessory of the approved SCS, DBS, and DRG Neurostimulation systems: 1) Second-tier supplier manufacturing process relocation2) Validation of new, equivalent equipment at new site
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