FDA-Device2015-11-18Class II
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Boston Scientific Corporation
Hazard
Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
Sold states
Distributed in the US to MA and PR.
Affected count
3
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2016Don't want to check this manually?
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