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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRX5000(TM) PROGRAMMER
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTON SCIENTIFIC
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
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