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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/RELIANCE S
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS035
Date Received09/13/2000
Decision Date11/02/2000
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE LUBRICIOUS COATING, REMOVAL OF ONE SUTURE SLEEVE (ON MODELS 127, 128, 147, 148), REDUCTION OF THE YOKE (ON MODELS 147, 148, 149), AND ADDITION OF THE PUERTO RICO FACILITY FOR PACKAGING, LABELING, AND STERILIZATION.
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