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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMICRONY FAMILY OF PACEMAKERS
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namepulse-generator, single chamber, sensor driven, implantable
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP970013
Supplement NumberS017
Date Received04/06/2007
Decision Date05/07/2007
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING: ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
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