# P020024: Amplatzer Duct Occluder and 180 Degree Delivery System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: May 14, 2003 after 324 days
- Product code: MAE (Occluder, Patent Ductus, Arteriosus)
- Device class: 3
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 25, 2008 · Not classified · Z-2192-2008: AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed 
- Oct 2, 2006 · Not classified · Z-0255-2007: AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a pot
- Oct 2, 2006 · Not classified · Z-0256-2007: AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a pot
- Sep 6, 2005 · Not classified · Z-0461-06: The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could po
- Nov 23, 2004 · Not classified · Z-0350-05: Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to

Source page: https://510kreport.com/device/P020024
Methodology: https://510kreport.com/methodology