PMA P120021S026
- Device
- Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P120021
- Supplement
- S026
- Product code
- MLV
- Decision date
- 2024-12-13
- Classification
- Cardiovascular
- Generic name
- Transcatheter septal occluder
- Approval order statement
- an additional sterilization chamber (Chamber #71) at Isomedix Operations, Inc. (Minneapolis, MN)
Current openFDA PMA Record#
- Device
- Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P120021
- Supplement
- S026
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2024-12-13
- Decision code
- OK30
- Date received
- 2024-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional sterilization chamber (Chamber #71) at Isomedix Operations, Inc. (Minneapolis, MN)