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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 NumberS001
Date Received09/19/2023
Decision Date11/02/2023
Product Code QWC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220004.
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