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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.
 
DevicePHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS012
Date Received05/15/2000
Decision Date06/22/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE PHILOS PULSE GENERATOR FAMILY AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHILOS DR, PHILOS DR-B, PHILOS D, PHILOS SR, PHILOS SR-B, PHILOS S, PHILOS SLR, AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE.
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