PMA P000039S081
- Device
- Amplatzer Septal Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P000039
- Supplement
- S081
- Product code
- MLV
- Decision date
- 2025-03-05
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- a change in air quality sampling test method and air microbe action and alert levels used in Abbott’s internal quality monitoring procedures
Current openFDA PMA Record#
- Device
- Amplatzer Septal Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P000039
- Supplement
- S081
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2025-03-05
- Decision code
- OK30
- Date received
- 2025-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in air quality sampling test method and air microbe action and alert levels used in Abbott’s internal quality monitoring procedures