PMA P030054S321
- Device
- Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S321
- Product code
- NIK
- Decision date
- 2017-10-20
- 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 Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.
Current openFDA PMA Record#
- Device
- Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S321
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-10-20
- Decision code
- APPR
- Date received
- 2017-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.