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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.
 
Trade NameMEDTRONIC KAPPA 700/600 PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
PMA NumberP980035
Supplement NumberS015
Date Received10/05/2001
Decision Date10/31/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate manufacturing, packaging and sterilization facilities at medtronic europe s. A. , tolochenaz, switzerland.
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