PMA P020024S066

Device: Amplatzer Duct Occluder, Amplatzer Duct Occluder II
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S066
Product code: MAE
Decision date: 2022-01-13
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Approval order statement: Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.

Current openFDA PMA Record#

Device: Amplatzer Duct Occluder, Amplatzer Duct Occluder II
Applicant: ABBOTT MEDICAL
PMA number: P020024
Supplement: S066
Product code: MAE
Generic name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Decision date: 2022-01-13
Decision code: APPR
Date received: 2021-11-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices.