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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 LEAD SYSTEM
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant
GUIDANT CORP.
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP050046
Supplement NumberS020
Date Received08/19/2013
Decision Date09/17/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Add a new primary supplier of the serial number labels for the defibrillation leads and coronary sinus leads for the devices.
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