- Device
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Amulet)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S016
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-02-24
- Decision code
- OK30
- Date received
- 2026-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the addition of an alternate silicone used for the silicone gasket of the Y-Connector Body of the Hemostasis Valve component of the Amplatzer Amulet Left Atrial Appendage Occluder