Atlas FDA

ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS

FDA premarket approval P910023/S128 · decided 2006-12-14

Approval details

PMA number
P910023
Supplement
S128
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS
Generic name
Pulse generator, permanent, implantable
Applicant
ABBOTT MEDICAL
Date received
2006-11-30
Decision date
2006-12-14
Days to decision
14 days
Decision code
APPR
Product code
NVZ
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
APPROVAL FOR: 1) AN ALTERNATE ELECTROLYTE (TM422) IN THE HIGH VOLTAGE CAPACITOR USED IN THE ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR AND EPIC II/II + DR/VR/HF DEVICES; AND 2) THE MINOR MODIFICATIONS TO THE CRYSTAL TUNING FORK USED IN EPIC, EPIC+, EPIC II/II +, ATLAS, ATLAS+, ATLAS II/II + DEVICES.

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