PMA P200049S018
- Device
- AmplatzerTM Amulet Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S018
- Product code
- NGV
- Decision date
- 2026-05-28
- Classification
- Cardiovascular
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- adding an alternate polyethylene terephthalate (PET) yarn supplier
Current openFDA PMA Record#
- Device
- AmplatzerTM Amulet Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S018
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-05-28
- Decision code
- OK30
- Date received
- 2026-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding an alternate polyethylene terephthalate (PET) yarn supplier