FDA-Device2016-01-20Class II
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Boston Scientific Corporation
Hazard
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Sold states
International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
Affected count
3
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0621-2016Don't want to check this manually?
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