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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.
 
DeviceMICRONY FAMILY OF PACEMAKERS
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP970013
Supplement NumberS037
Date Received10/12/2010
Decision Date11/08/2010
Product Code LWO 
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 ADHESIVE MIXING PROCESS USED IN PACEMAKER AND CRT-P MANUFACTURING.
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