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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/CONTOUR II/MD/ATLAS II/MD/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/ATLAS II/+/EPIC II/+/CONVERT
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS228
Date Received12/24/2009
Decision Date01/22/2010
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
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