PALMAZ MULLINS XD Pulmonary Stent

FDA premarket approval P220004 · Pulmonary stent

PMA numberP220004

Approval

Applicant
Cordis US Corp
Received
April 11, 2022
Decision date
July 21, 2023 (APPR)
Supplements
2, latest September 5, 2024
Product code
QWC – Pulmonary Stent

Official FDA PMA record

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.