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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 SYSTEM
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP050046
Supplement NumberS021
Date Received08/29/2013
Decision Date09/25/2013
Product Code OJX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
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