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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.
 
DeviceVITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS069
Date Received08/04/2005
Decision Date09/21/2005
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES.
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