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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.
 
DeviceRIATA FAMILY OF LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS034
Date Received12/19/2006
Decision Date03/08/2007
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES:1)MODIFICATION TO THE CRIMP SLUG WELD TAB 2) MODIFICATION TO THE DISTAL HEADER ASSEMBLY 3) MODIFICATION TO THE PTFE LINER IN THE IS-1 CONNECTOR LEG 4) REMOVAL OF THE PTFE LINERS IN THE TWO DF-1 CONNECTOR LEGS 5) ADDITION OF A DF-1 PLUG ACCESSORY TO THE LEAD PACKAGE 6) ADDITION OF AN EXTRA-SOFT STYLET ACCESSORY TO THE LEAD PACKAGE 7) MINOR MODIFICATIONS TO THE USER MANUAL 8) MODIFIED RADIUS SPECIFICATION FOR THE SPRING STOPPER COMPONENT.
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