FDA-Device2018-10-03Class II
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Boston Scientific Corporation
Hazard
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Sold states
AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3259-2018Don't want to check this manually?
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