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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.
 
DeviceENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS068
Date Received11/28/2006
Decision Date12/14/2006
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE MO16 SRAM PACKAGING FOR THE DEVICE HYBRIDS AND A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATA TO 4 ATA FOR THE ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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