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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 NameMETA(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M
Classification Nameimplantable pacemaker pulse-generator
Generic Namepacemaker
Regulation Number870.3610
ApplicantTELECTRONICS, INC.
PMA NumberP880038
Supplement NumberS033
Date Received08/09/1996
Decision Date09/30/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for amodification to the labeling regarding the proper insertio of a lead into the connector port.
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