PMA P030054S391
- Device
- Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S391
- Decision date
- 2021-04-09
- Approval order statement
- Adjust sample size for bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S391
- Decision date
- 2021-04-09
- Decision code
- OK30
- Date received
- 2021-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust sample size for bacterial endotoxin testing.