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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.
 
DeviceTHINLINE ENDOCARDIAL PACING LEADS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960004
Supplement NumberS001
Date Received01/27/1997
Decision Date08/29/1997
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the ThinLine(TM) EZ Model 438-10 Endocardial Pacing Lead. This device is indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator.
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