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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 NameMODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable, unipolar, multiprogrammable pulse g
ApplicantBIOTRONIK, GMBH & CO.
PMA NumberP820076
Supplement NumberS019
Date Received05/02/1995
Decision Date01/24/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model pms 1000 programming and monitoring system with software module swm 1000, version c01. C02. U.
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