PMA P200049S017
- Device
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S017
- Product code
- NGV
- Decision date
- 2026-03-19
- Classification
- Cardiovascular
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- to add an alternate supplier for the Swivel Luer Coupler component used in the Amplatzer™ Amulet ™ Left Atrial Appendage Occluder
Current openFDA PMA Record#
- Device
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S017
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-03-19
- Decision code
- OK30
- Date received
- 2026-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternate supplier for the Swivel Luer Coupler component used in the Amplatzer™ Amulet ™ Left Atrial Appendage Occluder