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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.
 
DevicePOLY-SAFE(TM) A-TRACK(TM) PACING LEADS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantCardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast, FL 32164
PMA NumberP890039
Supplement NumberS016
Date Received07/19/1996
Decision Date11/09/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the use of BioSpan(R) (MS/0.4 as a raw material for the polyurethane insulation for the above lead models.
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