PMA P020024S056
- Device
- Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S056
- Product code
- MAE
- Decision date
- 2019-03-25
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Modification to the air quality testing method and air microbe action and alert levels.
Current openFDA PMA Record#
- Device
- Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S056
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2019-03-25
- Decision code
- OK30
- Date received
- 2019-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the air quality testing method and air microbe action and alert levels.