PMA P020024S067

Device: Amplatzer Piccolo™ Occluder
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S067
Product code: MAE
Decision date: 2023-03-27
Classification: Cardiovascular
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Approval order statement: Approval for modifications to the Instructions for Use to include the 3-year follow up data on patients enrolled in the ADO II AS Clinical Study (IDE and Continued Access Cohorts).

Current openFDA PMA Record#

Device: Amplatzer Piccolo™ Occluder
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S067
Product code: MAE
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Decision date: 2023-03-27
Decision code: APPR
Date received: 2022-11-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for modifications to the Instructions for Use to include the 3-year follow up data on patients enrolled in the ADO II AS Clinical Study (IDE and Continued Access Cohorts).