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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 MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantTELECTRONICS PACING SYSTEMS, INC.
PMA NumberP820018
Supplement NumberS070
Date Received08/05/1996
Decision Date10/03/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the labeling to include information regarding the use of cellular telephones with patients wearing these devices.
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