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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 AND CRIBRIFORM OCCLUDERS
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP000039
Supplement NumberS046
Date Received05/14/2012
Decision Date06/06/2012
Product Code MAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF DIFFERENT BRAIDING EQUIPMENT TO REDUCE THE POTENTIAL FOR ABRASION OF NITINOL WIRE.
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