PMA P020024S071
- Device
- Amplatzer™ Duct Occluder; Amplatzer™ Duct Occluder II; Amplatzer Piccolo™ Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S071
- Product code
- MAE
- Decision date
- 2025-10-23
- Classification
- Cardiovascular
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- parametric release for the specified chamber/cycle at Steris AST (Minneapolis, MN).
Current openFDA PMA Record#
- Device
- Amplatzer™ Duct Occluder; Amplatzer™ Duct Occluder II; Amplatzer Piccolo™ Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S071
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2025-10-23
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- parametric release for the specified chamber/cycle at Steris AST (Minneapolis, MN).