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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.
 
DeviceDURATA FAMILY OF LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP950022
Supplement NumberS069
Date Received04/22/2010
Decision Date01/24/2011
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR 1) DESIGN MODIFICATIONS TO THE SUTURE SLEEVE OF ALL COMMERCIALLY AVAILABLE DURATA LEADS; 2) 7F SUTURE SLEEVE ACCESSORY KIT COMPATIBLE WITH ALL SJM 7F LEADS; 3) REDUCTION IN PVP (FASTPASS) COATING LENGTH FOR ALL DUAL-SHOCK VERSIONS OF COMMERCIALLY AVAILABLE DURATA LEADS; AND 4) DESIGN MODIFICATIONS TO THE IS-1 CONNECTOR CRIMP CONNECTION FOR ALL TRIFURCATED VERSIONS OF THE COMMERCIALLY- AVAILABLE DURATA LEADS.
Approval OrderApproval Order
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