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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.
 
DevicePALMAZ MULLINS XD Pulmonary Stent
Generic NamePulmonary stent
ApplicantCordis US Corp
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP220004
Supplement NumberS002
Date Received08/06/2024
Decision Date09/05/2024
Product Code QWC 
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  
an updated packaging configuration without physical Instructions for Use
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