PMA P020024S047
- Device
- AMPLATZER DUCT OCCLUDER/DUCT OCCLUDER II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S047
- Product code
- MAE
- Decision date
- 2017-02-22
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Implementation of an automated environmental monitoring system.
Current openFDA PMA Record#
- Device
- AMPLATZER DUCT OCCLUDER/DUCT OCCLUDER II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S047
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2017-02-22
- Decision code
- OK30
- Date received
- 2017-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated environmental monitoring system.