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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.
 
DeviceACUITY STEERABLE LEAD SYSTEM
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantGUIDANT CORP.
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP050046
Supplement NumberS020
Date Received08/19/2013
Decision Date09/17/2013
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES.
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