FDA-Device2024-05-08Class II
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Abbott Medical
Hazard
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Sold states
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, 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, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending
Affected count
10,610 units
Manufactured in
15900 Valley View Ct, Sylmar, CA, United States
Products
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2024Don't want to check this manually?
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