PMA P020024S053
- Device
- Amplatzer Duct Occluder/Amplatzer Duct Occluder II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S053
- Product code
- MAE
- Decision date
- 2019-01-08
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Change to the stock and adhesive for package labels.
Current openFDA PMA Record#
- Device
- Amplatzer Duct Occluder/Amplatzer Duct Occluder II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S053
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2019-01-08
- Decision code
- OK30
- Date received
- 2019-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the stock and adhesive for package labels.