PMA P030054S295
- Device
- PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S295
- Product code
- NIK
- Decision date
- 2016-04-28
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for the reassessment of microbiological levels for cleanrooms.
Current openFDA PMA Record#
- Device
- PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S295
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-04-28
- Decision code
- APPR
- Date received
- 2015-10-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the reassessment of microbiological levels for cleanrooms.