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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.
 
DeviceRX 7000 PROGRAMMING SYSTEM
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP830026
Supplement NumberS074
Date Received10/09/1998
Decision Date02/18/1999
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software. The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators.
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