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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 NameACTROS FAMILY OF PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator; pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS014
Date Received05/30/2000
Decision Date06/20/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to smaller blister packaging in the manufacturing process of all current and future bipolar pulse generator families.
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