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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 IS-1 LEADS
Generic NamePermanent defibrillator electrodes
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP050046
Supplement NumberS012
Date Received12/02/2011
Decision Date03/05/2012
Product Codes OJX NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING.
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