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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.
 
DeviceAFFINITY FAMILY OF PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS079
Date Received10/16/2000
Decision Date11/21/2000
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A LAYER OF KAPTON TAPE (A POLYIMIDE FILM) TO THE EDGE SIDE OF THE DEVICES' BATTERY CASE OF THE AFFINITY FAMILY OF PULSE GENERATORS.
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