PMA P020024S062
- Device
- Amplatzer Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- Product code
- MAE
- Decision date
- 2020-07-09
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Approval for updates to the Amplatzer Piccolo occluder Instructions for Use (IFU).
Current openFDA PMA Record#
- Device
- Amplatzer Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S062
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2020-07-09
- Decision code
- APPR
- Date received
- 2020-04-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Amplatzer Piccolo occluder Instructions for Use (IFU).