PMA P020024S052
- Device
- AMPLATZER Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S052
- Product code
- MAE
- Decision date
- 2019-01-11
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Approval for the AMPLATZER Piccolo Occluder.
Current openFDA PMA Record#
- Device
- AMPLATZER Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S052
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2019-01-11
- Decision code
- APPR
- Date received
- 2018-08-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the AMPLATZER Piccolo Occluder.