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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.
 
DeviceIsoFlex
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS076
Date Received07/14/2022
Decision Date08/01/2022
Product Code NVN 
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  
Implementation of the automated system Vaisala EMS system for environmental and process equipment monitoring at the Rogers, Minnesota manufacturing site.
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