Dorsal Root Ganglion (DRG) Stimulation System
FDA premarket approval P150004/S045 · decided 2021-07-02
Approval details
- PMA number
- P150004
- Supplement
- S045
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dorsal Root Ganglion (DRG) Stimulation System
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-03-10
- Decision date
- 2021-07-02
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for a cleaning process change that replaces the Trichloroethylene (TCE) cleaning agent, used in the first ultrasonic cleaning step to clean Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) needles, with CleanSafe-501ESF (CS-501ESF).
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