PMA P200049S006
- Device
- Amplatzer Amulet Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S006
- Product code
- NGV
- Decision date
- 2024-06-26
- Classification
- Cardiovascular
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- a reduction in the sample size tested for bacterial endotoxins
Current openFDA PMA Record#
- Device
- Amplatzer Amulet Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S006
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2024-06-26
- Decision code
- OK30
- Date received
- 2024-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a reduction in the sample size tested for bacterial endotoxins