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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.
 
DeviceRELIANCE LEADS FLUORO RING
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS059
Date Received11/09/2005
Decision Date12/08/2005
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A SECOND SUPPLIER FOR THE FLUORO RING COMPONENT USED FOR IDENTIFYING THE POSITION OF THE ELECTRODE DURING FLUOROSCOPY.
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