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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
Generic NamePermanent defibrillator electrodes
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP050046
Supplement NumberS002
Date Received11/23/2007
Decision Date03/05/2008
Product Code 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 A SPECIFICATION CHANGE FOR ACCEPTANCE OF SILICONE TUBING USED TO MANUFACTURE ACUITY STEERABLE LEADS.
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