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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.
 
DeviceFRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030035
Supplement NumberS001
Date Received07/21/2004
Decision Date08/16/2004
Product Code NKE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FRONTIER II MODEL 5586 BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE.
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