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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.
 
DeviceAMPLATZER SEPTAL OCCLUDER AND PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP000039
Supplement NumberS006
Date Received07/22/2003
Decision Date08/21/2003
Product Code MAE 
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  
ALTERNATE SUPPLIER FOR THE DELIVERY SHEATH, DILATOR, AND LOADING DEVICE COMPONENTS OF THE AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS AND SOME MINOR MANUFACTURING CHANGES TO ALLOW FOR COLOR CODING OF COMPONENTS.
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