PMA P020024S048
- Device
- AMPLATZER Duct Occluder II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S048
- Product code
- MAE
- Decision date
- 2017-09-21
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Approval for the AMPLATZER Duct Occluder II Instructions for Use, which has been updated to include the results of the completed post approval study.
Current openFDA PMA Record#
- Device
- AMPLATZER Duct Occluder II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S048
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2017-09-21
- Decision code
- APPR
- Date received
- 2017-06-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the AMPLATZER Duct Occluder II Instructions for Use, which has been updated to include the results of the completed post approval study.