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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS008
Date Received03/01/1999
Decision Date08/24/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.