- Device
- Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S064
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2020-06-04
- Decision code
- OK30
- Date received
- 2020-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of parametric release as part of the sterilization process at the Midwestern Sterilization Corporation facility.