PMA P000039S075
- Device
- Amplatzer Septal Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P000039
- Supplement
- S075
- Product code
- MLV
- Decision date
- 2021-09-22
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Addition of a sterilization chamber (Chamber 5) at the Steris sterilization facility in Costa Rica.
Current openFDA PMA Record#
- Device
- Amplatzer Septal Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P000039
- Supplement
- S075
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2021-09-22
- Decision code
- OK30
- Date received
- 2021-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a sterilization chamber (Chamber 5) at the Steris sterilization facility in Costa Rica.