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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.
 
DeviceCADENCE/CADET/CONTOUR/II/MD/ATLAS II/MD/+/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/EPIC II/+/CONVERT
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS227
Date Received11/25/2009
Decision Date05/11/2011
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
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