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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.
 
DeviceVENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS023
Date Received06/06/2001
Decision Date06/27/2001
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT GUIDANT IRELAND, CLONMEL TIPPERARY, IRELAND AND ALTERNATE STERILIZATION FACILITIES LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND AND GUIDANT, ST. PAUL, MINNESOTA.
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