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St. Jude Medical, Cardian Rhythm Management Division
FDA Regulatory Profile
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1530-2021 | Class I | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacema | March 15, 2021 |
| Z-1531-2021 | Class I | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and | March 15, 2021 |