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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(TM)II/FINELINE(TM) II LEADS
Generic Namepermanent pacemaker Electrode
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960004
Supplement NumberS013
Date Received05/15/2000
Decision Date06/09/2000
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT GUIDANT PUERTO RICO B.V., DORADO, PUERTO RICO, 00646 AND THE STERILIZATION FACILITY LOCATED AT GUIDANT CORPORATION, ST. PAUL, MINNESOTA, 55112.
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