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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
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP830026
Supplement NumberS066
Date Received02/01/1996
Decision Date03/22/1996
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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