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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 NumberS004
Date Received02/04/2009
Decision Date06/26/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval of a new pull tester.
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