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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.
 
DeviceRES-Q(TM) MICRON ICD SYSTEM
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP940008
Supplement NumberS009
Date Received12/24/1997
Decision Date03/17/1998
Withdrawal Date07/20/2012
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for new Models of Res-Q(TM) Micron ICD (Models 101-10 and 101-10A) and modifications to the existing Res-Q(TM) Micron ICD Models 101-05, and 101-09.
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