PMA P830045S091

Device: EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S091
Product code: KRG
Decision date: 2004-04-09
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR THE USE OF TANTALUM CAPACITORS IN EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T PULSE GENERATORS (P910023/S072) AND THE MODEL 3307 PROGRAMMER SOFTWARE V 4.6M (P830045/S091 AND P880086/S099). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T AND MODEL 3307 PROGRAMMER SOFTWARE V 4.6M.

Current openFDA PMA Record#

Device: EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S091
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2004-04-09
Decision code: APPR
Date received: 2004-03-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF TANTALUM CAPACITORS IN EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T PULSE GENERATORS (P910023/S072) AND THE MODEL 3307 PROGRAMMER SOFTWARE V 4.6M (P830045/S091 AND P880086/S099). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T AND MODEL 3307 PROGRAMMER SOFTWARE V 4.6M.