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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 NameREFLEX MODEL 8223E
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantTELECTRONICS PACING SYSTEMS, INC.
PMA NumberP820018
Supplement NumberS068
Date Received08/15/1995
Decision Date10/10/1995
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a polyamide insulator to the telemetry coil.
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