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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.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP830026
Supplement NumberS066
Date Received02/01/1996
Decision Date03/22/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of labeling addressing compatibility of pacemakers with cellular telephones. Specifically, the following models are affected:cosmos ii 284-05/283-03 -- nova ii 282-04/281-05/281-05s/282-04r/282-04y -- quantum ii 254-30/253-25 -- nova iii 282-09/282-09r/282-07/281/07 -- quantum iii 254-27 -- suprima iii 254-31.