DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit
FDA premarket approval P150004/S022 · decided 2018-05-19
Approval details
- PMA number
- P150004
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-04-20
- Decision date
- 2018-05-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Addition of the St. Jude Medical Portland facility as an alternate location for the extrusion of the conductor wires used in the Dorsal Root Ganglion (DRG) leads and extensions.
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