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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 DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator, pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS004
Date Received08/31/1998
Decision Date09/24/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a slightly downsized header for the actros dr, d, sr, and s pulse generators as well as approval for the actros dr-a which is compatible with 5-mm leads and the actros sr-b which is compatible with 6-mm leads. The device, as modified, will be marketed under the trade name actros pacing system which consists of the following: actros dr, d, sr, s, dr-a, and sr-b models, pms 1000 c programmers, swm 1000 (version f03. B00. U).
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