Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
FDA premarket approval P150004/S062 · decided 2023-07-21
Approval details
- PMA number
- P150004
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-06-23
- Decision date
- 2023-07-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Utilize previously validated Cycle 59 parameters in chamber 6 to the alternate chamber 13 to increase chamber capacity for sterilizing the same Abbott neuromodulation products.
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510(k) clearances by this applicant
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|---|---|---|
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |