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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.
 
DeviceMODELS 925, 2040, 2041, 6564
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP840068
Supplement NumberS001
Date Received01/16/1986
Decision Date04/15/1986
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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