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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.
 
DeviceAV PLUS DX
Generic Nameimplantable pacemaker Pulse-generator
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS077
Date Received08/11/2000
Decision Date09/07/2000
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
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