PMA P220004S001

Device: PALMAZ MULLINS XD Pulmonary Stent
Applicant: Cordis US Corp
PMA number: P220004
Supplement: S001
Product code: QWC
Decision date: 2023-11-02
Classification: Cardiovascular
Generic name: Pulmonary stent
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.

Current openFDA PMA Record#

Device: PALMAZ MULLINS XD Pulmonary Stent
Applicant: Cordis US Corp
PMA number: P220004
Supplement: S001
Product code: QWC
Generic name: Pulmonary stent
Decision date: 2023-11-02
Decision code: APPR
Date received: 2023-09-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.