FDA-Device2025-01-08Class II
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Medtronic Neuromodulation
Hazard
Software issues were identified in application version 2.x.
Sold states
Worldwide - US Nationwide distribution.
Affected count
3981 systems
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0774-2025Don't want to check this manually?
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