Atlas FDA

ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5

FDA premarket approval P910023/S077 · decided 2005-06-17

Approval details

PMA number
P910023
Supplement
S077
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5
Generic name
Pulse generator, permanent, implantable
Applicant
ABBOTT MEDICAL
Date received
2005-04-12
Decision date
2005-06-17
Days to decision
66 days
Decision code
APPR
Product code
NVZ
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
APPROVAL FOR THE ICD FIRMWARE VERSION 6.6.7 FOR EPIC MODELS V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, EPIC PLUS MODELS V-236, V-196, ATLAS AND ATLAS PLUS MODELS V-242, V243, V-193, V-193C, V340, V-343; AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5.

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