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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.
 
DeviceCONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS081
Date Received08/08/2005
Decision Date05/11/2006
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CONVERT AND CONVERT+ ICD SYSTEMS WITH THE APPLICATION SOFTWARE MODEL 3307 VERSION 4.9. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONVERT AND CONVERT+ ICD SYSTEMS AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (MODEL V-195 ONLY) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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