St, Jude Medical Infinity Deep Brain Stimulation (DBS) Leads
FDA premarket approval P140009/S041 · decided 2018-11-14
Approval details
- PMA number
- P140009
- Supplement
- S041
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- St, Jude Medical Infinity Deep Brain Stimulation (DBS) Leads
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-10-18
- Decision date
- 2018-11-14
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval to add X-ray inspections during the manufacture of the electrode subassemblies to enhance the safety of the leads for the Infinity Deep Brain Stimulation System.
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