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Device | PALMAZ MULLINS XD Pulmonary Stent |
Generic Name | Pulmonary stent |
Applicant | Cordis US Corp. 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P220004 |
Date Received | 04/11/2022 |
Decision Date | 07/21/2023 |
Product Code |
QWC |
Docket Number | 23M-3903 |
Notice Date | 09/18/2023 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the PALMAZ MULLINS XD Pulmonary Stent. The PALMAZ MULLINS XD Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 |