FDA-Device2018-10-03Class II
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Boston Scientific Corporation
Hazard
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Sold states
Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland
Affected count
74 units
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3260-2018Don't want to check this manually?
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