PMA P200049S001
- Device
- Amplatzer Amulet Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S001
- Product code
- NGV
- Decision date
- 2021-09-22
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Addition of a sterilization chamber (Chamber 5) at the Steris sterilization facility in Costa Rica.
Current openFDA PMA Record#
- Device
- Amplatzer Amulet Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S001
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- 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.