FDA-Device2025-01-08Class II
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Medtronic Neuromodulation
Hazard
Software issues were identified in application version 2.x.
Sold states
Worldwide - US Nationwide distribution.
Affected count
59 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 CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0772-2025Don't want to check this manually?
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