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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 STYLET ACCESSORY
Generic NamePermanent defibrillator electrodes
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP050046
Supplement NumberS009
Date Received01/26/2011
Decision Date06/29/2011
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ACCEPTANCE OF A CHANGE TO RELOCATE A SENSOR ON WIRE GRINDING EQUIPMENT AND FORMALIZE INSPECTIONS AS ACCEPTANCE ACTIVITIES.
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