PMA P200049S008
- Device
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S008
- Product code
- NGV
- Decision date
- 2024-12-13
- Classification
- Cardiovascular
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- an additional sterilization chamber (Chamber #71) at Isomedix Operations, Inc. (Minneapolis, MN)
Current openFDA PMA Record#
- Device
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S008
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- 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)