PMA P020024S046
- Device
- AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S046
- Product code
- MAE
- Decision date
- 2016-08-04
- Classification
- Occluder, Patent Ductus, Arteriosus
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Approval order statement
- Change to the pre-sterilization bioburden action and alert levels.
Current openFDA PMA Record#
- Device
- AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S046
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2016-08-04
- Decision code
- OK30
- Date received
- 2016-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the pre-sterilization bioburden action and alert levels.