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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 NameINTERTACH(R)II MODELS 262-16
Classification Namepulse-generator, single chamber, single
Generic Namesingle chamber, antitachycardia, pulse generator
ApplicantINTERMEDICS, INC.
PMA NumberP860007
Supplement NumberS017
Date Received02/01/1996
Decision Date03/22/1996
Product Code
LWW
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of labelng addressing compatibility of pacemakers with cellular telephones. Specifically the following models are affected:intertach ii 262-16/262-16r.
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