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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 PACEMAKERS
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP970013
Supplement NumberS019
Date Received04/23/2007
Decision Date05/09/2007
Product Code LWO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
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