Proclaim SCS Neurostimulation System
FDA premarket approval P140009/S062 · decided 2021-01-19
Approval details
- PMA number
- P140009
- Supplement
- S062
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Proclaim SCS Neurostimulation System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-07-14
- Decision date
- 2021-01-19
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for addition of BurstDR programs with multiple stimsets for Proclaim SCS System, programming enhancements for SCS therapy, cybersecurity enhancements and other minor enhancements for improvement. Approval for cybersecurity enhancements and other minor enhancements for improvement.
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