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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nametranscatheter septal occluder
Generic Nameseptal occluder
PMA NumberP050006
Supplement NumberS040
Date Received06/04/2014
Decision Date07/02/2014
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with usp <61> and usp <62>.