FDA Product Code MXC: Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Leading manufacturers include Abbott Medical.
23
Total
23
Cleared
102d
Avg days
1998
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) Devices (Product Code MXC)
23 devices
About Product Code MXC - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code MXC since 1998, with 23 receiving FDA clearance (average review time: 102 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MXC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →