PMA P030054S302
- Device
- Quadra Assura/Unify Assura Family of CRt-Ds
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S302
- Product code
- NIK
- Decision date
- 2016-06-28
- 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 Merlin PCS Model 3330 v22.0.1 Software.
Current openFDA PMA Record#
- Device
- Quadra Assura/Unify Assura Family of CRt-Ds
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S302
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-06-28
- Decision code
- APPR
- Date received
- 2016-04-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Merlin PCS Model 3330 v22.0.1 Software.