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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.
 
Trade NameACUITY STEERABLE LEAD
Classification Namepermanent defibrillator electrodes
ApplicantGUIDANT CORP.
PMA NumberP050046
Supplement NumberS002
Date Received11/23/2007
Decision Date03/05/2008
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a specification change for acceptance of silicone tubing used to manufacture acuity steerable leads.
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