PMA P030054S291
- Device
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S291
- Product code
- NIK
- Decision date
- 2016-02-12
- 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 Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
Current openFDA PMA Record#
- Device
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S291
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-02-12
- Decision code
- APPR
- Date received
- 2015-08-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.