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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.
 
DeviceCONTAK RENEW 3 RF
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS151
Date Received06/18/2007
Decision Date08/24/2007
Product Code LWP 
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 THE FOLLOWING CHANGES TO THE CONTAK RENEWAL 3 RF MODELS H210, H215, H217, AND H219: 1) DIGITAL IC PAD CHANGE TO ADDRESS PREMATURE BATTERY DEPLETION. 2) HYBRID MOTHERBOARD DFN TRACE RE-ROUTING FROM OUTSIDE LAYER ?4? TO AN INSIDE LAYER ?3? TO REDUCE ELECTRICAL FIELD INTENSITY AND POSSIBLE ARCING. 3) TRIM TARGET ADJUSTMENT.
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