Sorin CRM SAS

FDA Regulatory Profile

Sorin CRM SAS appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2824-2018, Class II) was initiated on July 9, 2018.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2824-2018Class IISorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and ResynchronizatioJuly 9, 2018
Z-2825-2018Class IISorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and ResynchronizatioJuly 9, 2018