St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, St. Jude Medical In
FDA premarket approval P140009/S070 · decided 2021-07-15
Approval details
- PMA number
- P140009
- Supplement
- S070
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, St. Jude Medical In
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-06-15
- Decision date
- 2021-07-15
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for labeling updates to include additional clarification language related to magnets within consumer goods and electronic devices.
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