PMA P220004S002

Device
PALMAZ MULLINS XD Pulmonary Stent
Applicant
Cordis US Corp
PMA number
P220004
Supplement
S002
Product code
QWC
Decision date
2024-09-05
Classification
Cardiovascular
Generic name
Pulmonary stent
Approval order statement
an updated packaging configuration without physical Instructions for Use

Current openFDA PMA Record#

Device
PALMAZ MULLINS XD Pulmonary Stent
Applicant
Cordis US Corp
PMA number
P220004
Supplement
S002
Product code
QWC
Generic name
Pulmonary stent
Decision date
2024-09-05
Decision code
OK30
Date received
2024-08-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an updated packaging configuration without physical Instructions for Use