- Device
- ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S088
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 2003-10-17
- Decision code
- APPR
- Date received
- 2003-09-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATIONS