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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceACUITY STEERABLE FAMILY OF LV PACING LEADS
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
GUIDANT CORP.
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP050046
Supplement NumberS017
Date Received10/02/2012
Decision Date11/09/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
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